Manager Of Regulatory Affairs Jobs in Texas

Job Title: Regulatory Affairs Manager Company: Stryker Location: Flower Mound, TX Description: BASIC FUNCTION• Directs and coordinates activities and operations of quality assurance department and staff. Providing the leadership, mission and vision for Quality organization. • Developing, implementing and maintaining Quality Assurance and Regulatory Affairs systems and activities within FDA and international regulatory guidelines.• May act as appointed Management Representative.RESPONSIBILITIES• Coordinates with other managers and associates to identify critical success factors, develop measurement systems, and implement continuous process improvement methodologies.• Designs, develops, and implements comprehensive quality assurance programs.• Maintains, enforces, and measures quality assurance processes.• Defines and manages an end-to-end test environment including but not limited to selection of tools, methods, and process.• Responsible for product performance and continuous improvement efforts.• Reviews and evaluates services to correct deficiencies and formulate improvements.• Assures on-time delivery of new projects; ensures product quality, performance, and conformity with company established specifications.• Assists with the planning and implementation of new programs, services, and projects; monitors progress and evaluates results; recommends changes or other action as appropriate.• Maintains and manages department budget.• Reviews, analyzes, and implements technological changes to enhance performance and customer requirements.• Hires, trains, supervises, motivates, and develops quality assurance staff; manages schedules and workflow.• Maintains the Quality System: CAPA and Internal Audits.• Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.• Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.• Coordinates Outside Inspection of the Quality System: FDA and Notified Body auditors.• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.• Manages directly and/or through subordinate supervisors the activities of the Regulatory Affairs & Quality Assurance department.• Develops and conducts staff training.• Conducts performance/merit reviews.• Coordinates priorities with associated managers.

Job Title: Assistant Director, Regulatory Affairs - Surgical Company: Alcon Laboratories Location: Fort Worth, TX Description: Employer Information About Alcon Laboratories Alcon, Inc. is the world's leading eye care company with sales of $5.6 billion in 2007. The company’s nearly 13,000 employees worldwide, work in 75 facilities around the world to research, develop, manufacture and sell eye care products in more than 180 countries. Alcon is the largest specialty eye care company in the world and leads the growing $14.5 billion market for eye care products. Alcon has delivered strong and stable growth for over 60 years, and it is positioned to build on this record....more info View all our jobs Job Alcon, Inc. is the world's leading eye care company with sales of $6.5 billion in 2009. The company’s nearly 15,000 employees worldwide, work in 75 facilities around the world to research, develop, manufacture and sell eye care products in more than 180 countries. Alcon is the largest specialty eye care company in the world and leads the growing $14.5 billion market for eye care products. Alcon has delivered strong and stable growth for more than 60 years, and it is positioned to build on this record in the years to come. Fortune magazine has selected Alcon as "One of the 100 Best Companies to Work For". Alcon's U.S. Headquarters are at its 300-acre campus in Fort Worth, Texas. For more information on Alcon, Inc., visit the Company’s web site at www.alcon.com. Plans, directs and coordinates activities of designated major projects/program activities to ensure that aims, goals or specified objectives are accomplished in accordance with prescribed priorities, time limitations and resource/funding conditions. Acts as an advisor to subordinate, supervisor or staff members to help meet established schedules or resolve technical or operational problems. Submits and administers schedules and performance standards. May provide input to performance appraisal and have hiring, firing and disciplinary responsibility. Primary Accountabilities: • To achieve expeditious approval of Alcon surgical devices in global markets through effective planning and submission of high quality dossiers and applications. • Provide timely strategic and technical guidance to Project Teams, Research & Development, Marketing and Operations on regulatory matters related to device design, manufacturing, safety and clinical performance of surgical products. • Actively participate in establishing plans/timelines and reviewing regulatory requirements and specifications for registration purposes. Minimum Qualifications: Bachelor’s degree in appropriate scientific/technical discipline and 10+ years of experience since obtaining last degree OR Master’s degree in appropriate scientific/technical discipline and 7+ years of experience since obtaining last degree. Experience factors typically are related to prior scientific/technical achievements, background in management of a scientific/technical function and accomplishments in positions of leadership. Preferred Qualifications: • Previous experience in the ophthalmic industry • Background primarily in Class II or III implantable/surgical devices • Relevant experience with clinical trial management • Proven FDA submission experience focused more heavily on IDEs and PMAs Significant relevant experience with demonstrated leadership and ability to recognize and develop solutions in multi-discipline team situations is also required. Relocation Assistance is Available Alcon is an equal opportunity and affirmative action employer whose success rests upon the efforts and contributions of qualified people regardless of race, color, sex, sexual orientation, national origin, age, religion, disability, status as a qualified special disabled veteran, Vietnam era veteran, recently separated veteran, and any other veteran who served on active duty during a war, campaign or expedition for which a campaign badge has been authorized, or any other status or characteristic protected by law. Our generous benefits package includes the Alcon 401(k) Plan which matches employee contributions up to 5% of eligible pay at the rate of $1.00 for each dollar contributed, and the Alcon Retirement Plan (ARP), a qualified plan in which Alcon contributes 7% of eligible pay to the accounts of all eligible employees. By combining the Company's contributions to the 401(k) and ARP, employees can receive up to 12% of eligible pay from Alcon towards retirement. Alcon also offers medical, dental, vision, life and disability coverage, an on-site fitness center and much more. Consider having all this in a fast paced environment within a stable world-class organization. Alcon is an Equal Opportunity Employer committed to quality through diversity. M/F/D/V. Pre-employment drug testing. NOTES: Local Country Candidates Only. Employer will assist with relocation costs

Job Title: Manager, Regulatory Affairs - NERC & TRE Company: Energy Future Holdings Location: Dallas, TX Description: Summary: ·         Manager - NERC and TRE Affairs  will be responsible for planning, organizing, and coordinating Luminant's engagement with the North American Electric Reliability Corporation (“NERC”), the Texas Regional Entity ("TRE"), and the Federal Energy Regulatory Commission ("FERC").  ·         This position will work in close coordination with Luminant Power Generation Compliance and Luminant Energy Compliance.  ·         This position is responsible for  tracking all proposed rules, standards, guides, protocols, regulations, and laws that may impact Luminant's operations including those proposed, discussed, published or adopted by NERC or TRE to ensure Luminant has the opportunity to positively influence their development and implementation.  ·         This position will coordinate the preparation, submittal, and management of numerous filings, reports, investigations, and responses to requests for information of Luminant by NERC and TRE.    ·         This position serves as the primary responsible person for ensuring Luminant is informed of the activities necessary to be compliant with the applicable rules and regulations related to NERC and TRE.  This position serves as the Luminant Energy primary advocate in the NERC standards revision process and as Luminant's primary advocate in activities before the TRE. Key Roles & Responsibilities: ·         Represents Luminant Energy on the NERC Standards Drafting Teams for development and revision of standards. ·         Communicates & negotiates internally in order to develop optimal corporate positions and outcomes. ·         Coordinates activities with that of Luminant Power Generation Compliance and Luminant Energy Compliance teams. ·         Identifies existing and proposed rules and standards that may have an impact on the operations of Luminant.  Analyzes and helps prepare company filings/comments concerning on-going activities before NERC, TRE, and the FERC including standards development, Protocols revision, and other regulatory activities that may affect the operations of Luminant. ·         Provides strategic guidance to Luminant regarding the impacts of existing and proposed rules and standards. ·         Advocates Luminant's position in various forums relative to the activities of TRE. ·         Advocates Luminant Energy's position in various forums relative to the activities of NERC. ·         Directs and coordinates the preparation and participation of Luminant Energy in required TRE/NERC audits. Serves as a Subject Matter Expert (SME) on TRE/NERC Reliability Standards  by providing analysis and interpretation of those rules and regulations as requested.   Requirements Education & Experience Requirements: ·         The candidate should possess as a minimum a Bachelor's degree in a technical field; an advanced degree (Masters or equivalent) is not a requirement but would be desirable.  Registration as a professional engineer in the State of Texas is a plus. ·         Requires a strong and current knowledge of ERCOT wholesale market design, power plant operations and engineering and regulatory processes. Commercial experience required to assess economic impact on the company resulting from proposed rule or standard changes. ·         This position requires broad and extensive knowledge of the utility industry in general; policies and operations in particular; and experience in generation dispatch and trading operations. ·         Knowledge and understanding of all applicable ERCOT protocols, PUCT substantive rules, TRE, DOE, FERC, and NERC reliability standards related to Luminant's operations in the ERCOT market. ·         Must also have the ability to analyze proposals and to develop and implement strategies to advance the company’s position. ·         The candidate must possess excellent verbal, analytical, written, negotiational and presentation skills, he or she must be able to effectively communicate in writing and orally with peers, superiors, regulators and other nationwide industry participants. ·         The incumbent should have at least 10 years experience in the electric utility industry, five of which should be in Texas. Measures of Success: ·         Timely and accurately alerts Luminant regarding activities at TRE and NERC that may affect the its operation or finances. ·         Development and successful advocacy of positions that contibute to the success of Luminant. ·         Satisfactory completion of audits of Luminant Energy required by the TRE and/or NERC. ·         Accurately responds to questions on TRE/NERC Reliability Standards. ·         Maintains good working relationships with ERCOT, market participants, TRE, NERC, FERC and the PUCT. Luminant is an Affirmative Action/Equal Opportunity Employer

Job Title: eCTD / EDMS Manager Regulatory Affairs Company: Galderma Laboratories, L.P. Location: Fort Worth, TX Description: Manages eCTD Electronic Document Management Systems (EDMS) for Pharmaceutical Company (NDA's SPL's) ABOUT US: Created as a joint-venture between Nestle and L'Oreal in 1981, Galderma is the number one dermatology company in its markets focusing exclusively on meeting the needs of dermatology patients and physicians. This commitment translates into innovative therapeutic solutions for the diagnosis, prevention and treatment of dermatological conditions. We have an excellent opportunity for a Regulatory Affairs professional with experience with eCTD / EDMS (electronic filing) systems in the pharmaceutical environment.The position is based in Alliance which is 20 miles north of downtownFort Worth, TX. Galderma offers a very attractive package of salary, incentive pay and benefits. JOB DESCRIPTION: Manages electronic document management systems (EDMS) for regulatory activities. The systems include electronic new drug applications (NDAs), structured product labeling (SPL) and electronic drug listing. ESSENTIAL DUTIES/RESPONSIBILITIES Other duties may be assigned. Participates in the evaluation of proposed EDMS tools for possible use and purchase. Acts as the regulatory technical representative for all EDMS projects including but not limited to SPO systems, label approvals, electronic archiving, etc. Writes and maintains operating procedures describing EDMS activities at the local or US level. Provides training for users of EDMS systems at the local or US level. Assembles NDAs and drug listing submissions Provides technical expertise to assist in the assembly of submissions to NDAs, SPL and electronic drug listing. Maintains GLLP’s FDA electronic submission gateway (ESG) account. EDUCATION and/or EXPERIENCE : Bachelor's degree in life sciences or computer sciences or related field from a four-year college or university. Minimum of five years experience using electronic documentation systems. Experience with Liquent Insight Suite preferred. In order to function effectively, the incumbent must have a thorough working knowledge of the pharmaceutical industry including all regulatory requirements; the drug development process, including pre-clinical, clinical and product development; regulations describing the content and submission of drug product marketing authorizations in the United States. To APPLY for This Position CLICK HERE To view vacant positions visit our CAREERS PAGE Galderma is an equal opportunity employer M/F/D/V 11

Job Title: Regulatory Affairs Manager Company: EnerNOC, Inc. Location: Austin, TX Description: EnerNOC is transforming the way the world uses energy. We help commercial, institutional, and industrial organizations use energy more intelligently, pay less for it, and generate cash flow that benefits the bottom line. Our technology-enabled energy management solutions help meet the needs of transmission system operators, electricity suppliers, and distribution network operators that deliver energy and are responsible for maintaining the real-time balance between supply and demand. We bring proven expertise and innovative ideas to these partners through a full suite of energy management solutions including: Demand Response: Thousands of facilities in our network get paid for reducing their energy consumption during certain critical periods, while our utility customers get access to clean, reliable capacity where and when it is needed most. EnerNOC demand response is a win-win. Energy Efficiency: Our monitoring-based commissioning solution helps businesses and institutions uncover significant energy savings, often without the need to invest significant capital, leading to persistent energy cost and emission reductions. Energy Procurement: In deregulated markets such as the UK, our energy procurement solution helps businesses and institutions navigate complex energy markets and buy energy more cost-effectively. Put us to work to also help you procure the right mix of renewable energy for your facilities. EnerNOC, which stands for Energy Network Operations Center, has won numerous awards for its technology, customer service, and industry leadership. We attract bright, enthusiastic people who are dedicated to helping achieve a cleaner, safer and more cost-effective energy future.

Job Title: Regulatory Affairs Manager Job Company: Stryker Location: Flower Mound, TX Description: Regulatory Affairs Manager Job Job Title: Regulatory Affairs ManagerDivision: Stryker CommunicationsLocation: (Country - State) United States - TexasCity or Sales Region: Flower MoundBusiness Function: Regulatory/Quality/Clinical AffairsShift: 1stEducation and/or Special Training: EDUCATION/TRAINING REQUIRED Bachelor's degree (B.S.) or equivalent in related field. 4-6 years related experience or equivalent.Job Description: BASIC FUNCTION Directs and coordinates activities and operations of quality assurance department and staff. Providing the leadership, mission and vision for Quality organization. Developing, implementing and maintaining Quality Assurance and Regulatory Affairs systems and activities within FDA and international regulatory guidelines. May act as appointed Management Representative.RESPONSIBILITIES Coordinates with other managers and associates to identify critical success factors, develop measurement systems, and implement continuous process improvement methodologies. Designs, develops, and implements comprehensive quality assurance programs. Maintains, enforces, and measures quality assurance processes. Defines and manages an end-to-end test environment including but not limited to selection of tools, methods, and process. Responsible for product performance and continuous improvement efforts. Reviews and evaluates services to correct deficiencies and formulate improvements. Assures on-time delivery of new projects; ensures product quality, performance, and conformity with company established specifications. Assists with the planning and implementation of new programs, services, and projects; monitors progress and evaluates results; recommends changes or other action as appropriate. Maintains and manages department budget. Reviews, analyzes, and implements technological changes to enhance performance and customer requirements. Hires, trains, supervises, motivates, and develops quality assurance staff; manages schedules and workflow. Maintains the Quality System: CAPA and Internal Audits. Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations. Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance. Coordinates Outside Inspection of the Quality System: FDA and Notified Body auditors. Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions. Manages directly and/or through subordinate supervisors the activities of the Regulatory Affairs & Quality Assurance department. Develops and conducts staff training. Conducts performance/merit reviews. Coordinates priorities with associated managers.Qualifications/Work Experience: PHYSICAL REQUIREMENTS Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time.MENTAL REQUIREMENTS Demonstrated proficiency in managing and motivating subordinates. Commitment to excellence and high standards. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. Acute attention to detail. Demonstrated ability to plan and organize projects. Proficient on Microsoft Office (Word, Excel, Access and PowerPoint).SKILLS/EXPERIENCE REQUIRED Excellent written and oral communication skills. Basic competence in subordinates' duties and tasks. Ability to work with all levels of management. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow. Proven leadership and business acumen skills. Knowledge of applicable international regulations and standards (MDD, 13485 and CMDCAS). Proven ability to handle multiple projects and meet deadlines. Good judgment with the ability to make timely and sound decisions. Creative, flexible, and innovative team player. Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization. Must be able to communicate with large groups of people. Ability to work in a fast paced, constantly changing work environment.Percent Travel Required 10Requisition ID: 10867BR