Manager Of Regulatory Affairs Jobs in Texas

Job Title: Mgr, Regulatory Affairs I Company: Alcon, Inc. Location: Fort Worth, TX Description: Overall Job Summary: Under general supervision, prepares submission of regulatory documents with health authorities in obtaining marketing clearances for generics and for surgical therapeutics. Ensures the compliance of currently marketed products with applicable regulations. As the regulatory affairs interface on the generics team and surgical therapeutic project teams, coordinates the submission of ANDAs/ANDss, INDs/CTAs, NDAs/MAAs, progress reports, supplements, amendments, and periodic reports in collaboration with multi-discipline project teams. Ensures compliance with applicable regulations and interpretations related to reviewing, evaluating, and compiling files and reports for submission. Prefer Candidates with: Generics Experience IND & NDA and European drug registration experience e.g. MAA & CTAs Experience working with FDAMinimum Education Requirements: Masters degree.Minimum Experience Requirements: 5 years experience in the health care industry.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. Relocation Assistance is Available Alcon is an Equal Opportunity Employer committed to quality through diversity. Pre-employment drug testing.

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: Mgr, Regulatory Affairs II Company: Alcon, Inc. Location: Fort Worth, TX Description: Overall Job Summary: As the primary regulatory affairs interface on assigned project teams, the individual is responsible for submission of documentation for clinical trials (i.e., INDs/CTAs as well as their amendments and periodic reports) and for submission of marketing authorization dossiers (i.e., NDAs/MAAs as well as their amendments) in collaboration with the multi-disciplinary project teams. Additionally, the individual is responsible for reviewing regulations and guidance's, providing interpretation to the project teams, and ensuring that submitted dossiers are compliant with applicable regulations and guidance's. The primary regulatory interface on assigned project teams;responsible for providing regulatory guidance on the conduct ofglobal clinical trials and coordinating with Regional RA; responsible for the submission of regulatory documentation for conduct of clinical trials in the USA and maintenance of the IND; responsible for submission/coordination of global registrationdocuments. Prefer candidates with knowledge of Regulatory Affairs and Drug Development. Candidates with Glaucoma background and experience are strongly preferred. Minimum Education Requirements: Masters or PhD required (preferred in a scientific discipline.)Minimum Experience Requirements: 3 years of relevant experience in the healthcare industry. Relocation Assistance is AvailableAlcon is an Equal Opportunity Employer committed to quality through diversity. Pre-employment drug testing.

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: Senior Manager, Regulatory Affairs Company: Horizon Wind Energy Location: Houston, TX Description: Job ID: 437 Position Description: GENERAL DESCRIPTION In collaboration with the Director of Regulatory Affairs, directs and ensures EDPR NA's regulatory compliance with FERC, NERC, RTO, ISO, and state public utility commissions. Serves as the resident subject matter expert on regulatory requirements and compliance. MAIN ACCOUNTABILITIES oLeads cross-functional teams to ensure EDPR NA's compliance with regulatory requirements of NERC, FERC, RTO, ISO, and state public utility commissions oDevelops and manages key support processes (e.g., compliance monitoring systems and programs) on behalf of the Regulatory Affairs group oActs as a liaison between EDPR NA and FERC, NERC, regional entities, PUC, DOE, RTO, and other regulatory bodies for all regulatory compliance issues, including reporting requirements, audit requirements, and any applicable information requests regarding compliance regulations oParticipates in NERC and Regional Stakeholder committees in order to help formulate regulations and policies oParticipates in relevant market design/development stakeholder forums in order to ensure that the company's business model is considered in policy and rule creation oEnsures that regulatory requirements and trends are understood and are reflected in the company's commercial and operational business strategies oMonitors applicable NERC and regional entity standards and ensures that new or revised reliability standards are tracked appropriately oProvides details of standards to pertinent personnel in EDPR NA, allowing for timely feedback and compliance, and assembles and submits comments oCoordinates EDPR NA's participation in the development of NERC reliability standards, including providing oral or written comments and coordinating oral or written testimony provided by other EDPR NA personnel or consultants oDevelops and maintains strong collaborative relationships internally and with key allies, stakeholders, and policy-makers, including regulatory agencies oWorks with regional teams to build capacity for regulatory work oProvides support on disputes regarding any tariffs or protocols of an ISO or RTO as requested oProvides technical and logistical support to EDPR NA's business units as requested oInfluences stakeholders' expectations and opinions of the company, ensuring that EDPR NA is characterized by timely and thorough responsiveness to, and compliance with, regulatory standards oMaintains accountability for the Regulatory Affairs team's achievement of Key Performance Indicators (KPIs) oSupports EDPR NA's fulfillment of its strategic objectives via continual compliance with pertinent regulatory requirements oAdditional duties as required Position Requirements: REQUIRED EDUCATION: Bachelor's degree in Engineering, Business, Government, or Political Science; advanced degree preferred REQUIRED PROFESSIONAL EXPERIENCE: 7+ years in regulatory compliance, including demonstrated success achieving policy outcomes in diverse regulatory environments REQUIRED LICENSURE OR CERTIFICATION: REQUIRED KNOWLEDGE: Substantive knowledge of renewable energy issues OTHER REQUIREMENTS: Excellent written and oral communication skills An established network of contacts among industry organizations, regulatory agencies, and other key stakeholders Negotiation and conflict-management skills Ability to be highly self-motivated Strategic-planning skills Ability to be forward-thinking on regulatory issues Strong interpersonal and teamwork skills Ability to communicate complex issues to a diverse audience in a logical, open, and easily understood manner High attention to detail Analytical and problem-solving skills Ability to work independently Ability to produce solutions under significant time pressure Willingness and ability to travel frequently and maintain accessibility during off-hours Strong organizational skills . PLEASE APPLY USING THIS BUTTON ONLY

Job Title: International Regulatory Affairs Manager - RA Manager - Medical Device Company: Company Confidential Location: Dallas, TX Description: Regulatory Affairs Manager Well known medical device company East of Dallas. MUST HAVE IN ORDER TO BE CONSIDERED: * BS Degree required. Advanced degree preferred. * Minimum 5-years medical device regulatory affairs experience, especially international submissions. * Demonstrated knowledge of FDA regulations and International Conference of Harmonization (ICH) and Good Manufacturing Practices (cGMP). * Demonstrated knowledge of current US and international regulations and guidelines, the medical device development process, and for adverse event reporting. * Experience with regulatory filings and submissions (510(K), IDE, PMA) with favorable clearance and approval times. DUTIES & RESPONSIBILITIES: Obtains and generates information to be submitted to regulatory authorities and prepares required regulatory submissions. Acts as liaison with appropriate local, national and international regulatory authorities. Provides regulatory guidance to sales, marketing, and manufacturing groups, as appropriate. Review changes in manufacturing facilities, manufacturing procedures, and analytical methods. Represent regulatory on project planning and review meetings; participates in final document review and corrections. Identifies and ensures the establishment and monitoring schedules for submission documentation, review of documentation, protocols and reports received; prepares additional written materials as needed. Coordinates and prepares 510(k) Pre-market Notifications, IDEs, PMAs, Technical Files and Design Dossiers. Prepares responses to FDA letters, supplements, and amendments; participates in ISO and customer audits and FDA inspections and presentations. Writes departmental SOPs as needed. Provides input for preparation of departmental budget; ensures that the department operates within capital and expense budget guidelines. Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company. Read related regulatory publications and documents; presents information about current regulatory actions. Performs all other related duties as directed by management. THIS IS AN URGENT SEARCH! APPLYNOW!! KEY WORDS: Quality Assurance, QA, RA, Regulator Affairs, Q.A., biotech,orthopedic, transdermal, parenteral, injectable, class III, Class II, Class I, 13485, 13485:2003, FDA, 510K, 510 K, 510(K), IDE, PMA, 21CFR, 21 CFR Part 820, product marketing, capa, doe, fmea, dfmea, pfmea, six-sigma, six sigma, sigma, 14971, QSR, Quality Systems, Quality system, Qualty, RA Director, Regulatory Affairs, regulatory, 483, 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and Premarket Approval Applications, (PMAs), Risk management, design transfer, CAPA, Corrective and Preventative Action, Design dossier, Tech Files, Technical files, submissions, submission, audit, MNC, minor nonconformance, major nonconformance, MDR, medical device reporting, adverse event, recall, field corrective action, FCA, document control, good documentation practices, design history file, design master record, design history record