Director Of Regulatory Affairs Jobs in Georgia

Job Title: DIRECTOR, REG. AFFAIRS & QUAL. ASSURANCE Company: Kimberly-Clark Location: Roswell, GA Description: Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 35 countries, Kimberly-Clark posted sales of $19.1 billion in 2009. Kimberly-Clark's global brands are sold in more than 150 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries. Our success stems from leveraging insights from our customers, shoppers and users in the innovations we bring to market. This has led us to the development of entirely new products and categories, and improved performance in existing brands. Around the world, medical professionals turn to Kimberly-Clark Health Care for a wide portfolio of solutions that improve health, hygiene and well-being of their patients and staff. From family care to personal care, in safety, Do-It-Yourself and Home Improvement settings, we're driving our growth by enhancing the health, hygiene and well-being of people every day, everywhere. As a global company, we are committed to cultivating a fair, respectful and engaging work environment that inspires our diverse global team to thrive professionally and contribute to the communities where we operate. We also have a responsibility to attain a deeper understanding of our impact on the world. Addressing Sustainability issues and incorporating solutions through all levels of Kimberly-Clark is a critical component of our business. Throughout our 138-year history, Kimberly-Clark has adhered to a set of simple yet insightful values established by our founders quality, service and fair dealing. These are the standards of performance by which our leadership and employees are measured. These values have helped establish Kimberly-Clark as a leading-edge global company that produces superior essential products used by families and professionals from all walks of life and cultures around the world.We are currently seeking a Director for Regulatory Affairs/Quality Assurance (QA / RA) within the KC professional (KCP) sector at our Roswell, GA location. POSITION PURPOSE:Responsible to develop, implement and maintain global KCP quality and regulatory systems. Collaborate with regional and corporate teams to ensure KCP globally meets all quality system and regulatory requirements. Drive improvement in business processes where quality and regulatory involvement is needed, and advance KCP regulatory interests with key internal and external stakeholders.CUSTOMERS AND CUSTOMER REQUIREMENTS:Key customers include consuming customers, sector management, business teams, R&E teams, product supply and quality assurance teams, corporate regulatory affairs and quality assurance teams, external quality and regulatory bodies. Effective performance in this role will require:- Strong collaboration, communication and persuasiveness skills- Credibility with senior leadership internally and regulatory agencies externally- Working effectively across functional and geographic boundaries through influence- Visionary and strategy development skills- Business acumen a clear understanding of the business needs and key imperatives- Experience / aptitude for process re-design and organizational change management- Global breadth of experience and understanding- Quality systems backgroundSCOPE:The Director for Regulatory Affairs/Quality Assurance reports to the Vice President KCP Research and Engineering but will work closely with the Vice President Product Supply and Vice President KC Quality Assurance and Regulatory Affairs. The role supports the KC Professional sector globally. QUALIFICATIONS:- A minimum of a Bachelor's Degree in a relevant field is required. - Requires a minimum of 8-10 years experience in an industry dealing with relevant regulatory requirements and leading regulatory or quality systems implementation and management. - Experience having led or created a team and highly developed leadership capabilities combined with the ability to motivate and lead a diverse team and work in a matrix organization. PREFERRED QUALIFICATIONS:- Knowledge of KCP products, processes, and organization or similar industry experience is preferred- Experience with ISO certification- Experience with global regulations across multiple countriesDIMENSIONS:This is a new role for KCP. Regulatory affairs and quality assurance costs are currently rolled into various cost centers throughout the sector. Personnel: Direct reports: This role will initially be an individual contributor. Part of the job accountabilities will be to develop the KCP QA / RA organization. The result of this analysis could possibly pull QA / RA team members currently in other departments into a central organization.Work direction: will provide guidance to sector QA / RA team members. These team members reside in both staff and mill locations. Exact number is not yet determined. PRINCIPLE ACCOUNTABILTIES:- Lead and implement project to improve KCP regulatory capabilities- Complete process assessment for regulatory aspects of new product launches and implement process changes to yield reduced time to market success.- Provide regulatory advice and counsel to support global expansion business strategies.- Ensure ongoing compliance to regulatory and quality system requirements- Identify areas where KCP is at risk in regulatory and quality systems compliance and implement corrective actions- Develop and audit ongoing regulatory and quality systems for compliance, effectiveness and continuous improvement.- Ongoing process owner for KCP quality systems and regulatory processes- Represent and advance KCP regulatory interests with key stakeholders- Direct and prioritize the efforts of global and regional QA / RA teams.- Functional coordination and capability development of KCP global mill level quality teams and external manufacturing partners.- Be an advocate and sponsor for quality and regulatory excellence throughout the global KCP business.- Ensure KCP teams have the correct quality and regulatory capability- Ensure KCP interests are represented with regulatory agencies- Influence test methods, standards and legislation- Develop and Implement global KCP quality and regulatory strategy that provides competitive advantage and improves business results- Develop recommendations for KCP QA / RA strategy, systems and organization- Ensure that his/her career development activities occur in a timely manner.- Contribute to an environment in which all team members are respected, regardless of their individual differences. Be motivated to improve both the individual and team contributions to achieve desired business results.

Job Title: Regulatory Affairs Director Company: C. R. Bard, Inc Location: Covington, GA Description: Overview: The Regulatory Affairs Director is located at Bard Medical Division in Covington, Georgia. Summary of Position with General Responsibilities: The Director, Regulatory Affairs is responsible for the planning, coordinating and implementing the work for the Regulatory Affairs Department. Essential Job Functions: An active department leader that help drive decisions & success for the organizationManage, plan, and coordinate work of Regulatory Affairs department. Implement company and departmental goals, objectives, and enforce requirements of quality work. Participate in product development/SE teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document, and implement a regulatory submission plan around product development goals. Prepare U.S. FDA 5l0(k), IDE, PMA, submissions as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, scientifically based and meet Bard Corporate standards. Prepare and update Europeans and international product dossiers/registrations as required. Ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, scientifically based and meet Bard Corporate standards.Review all clinical and marketing study protocols for compliance with FDA, European, and international regulations and standards. Review all Engineering Change Orders for compliance with FDA, European, and international regulations and standards. Coordinate the review of FDA submissions and labeling by BARD Corporate Regulatory and Medical Affairs, and Legal Department.Assist Bard Corporate in updating establishment registrations and device listings as required. Develop Standard Operating Procedures (SOPs) implementing FDA, European, and international regulations and standards as appropriate.Ensure adequate documentation of compliance to FDA, European, and international regulations and standards. Ensure continuous update and maintenance of the Regulatory Affairs files. Develop working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance, and notified body. Basic Qualifications: ? Must have excellent written and verbal communication skills. ? Must be a team player. ? Must be able to prioritize and handle several projects concurrently. ? Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities. ? Sufficient computer skills (e.g., MS Word, MS Excel, MS PowerPoint, etc.). ? Must be able to meet goals on time ? Must have knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices. ? Must have knowledge with the requirements for medical device registration/licensing in the EU, Japan, Canada, Australia, Latin America and Asia/Pacific. ? Regulatory Affairs Certification (RAC) desired. Education and/or Experience: Minimum of eight years Regulatory Affairs related experience.Minimum three years supervisory experience. BS or BA degree in technical area such as biology, chemistry, physiology, engineering, medical or law. Comprehensive knowledge of United States, European, and international regulations and standards covering medical devices. Knowledge of the clinical application of medical devices, as applicable. Knowledge of medical device testing methods and statistics, as applicable. Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently Physical Demands: Must be able to operate computer and office equipment as needed. Must be able to travel via airlines as needed. Work Environment: Traditional office environment.

Job Title: DIRECTOR, REG. AFFAIRS Company: Company Confidential Location: Roswell, GA Description: Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 35 countries, Kimberly-Clark posted sales of $19.1 billion in 2009. Kimberly-Clark's global brands are sold in more than 150 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries. Our success stems from leveraging insights from our customers, shoppers and users in the innovations we bring to market. This has led us to the development of entirely new products and categories, and improved performance in existing brands. Around the world, medical professionals turn to Kimberly-Clark Health Care for a wide portfolio of solutions that improve health, hygiene and well-being of their patients and staff. From family care to personal care, in safety, Do-It-Yourself and Home Improvement settings, we're driving our growth by enhancing the health, hygiene and well-being of people every day, everywhere. As a global company, we are committed to cultivating a fair, respectful and engaging work environment that inspires our diverse global team to thrive professionally and contribute to the communities where we operate. We also have a responsibility to attain a deeper understanding of our impact on the world. Addressing Sustainability issues and incorporating solutions through all levels of Kimberly-Clark is a critical component of our business. Throughout our 138-year history, Kimberly-Clark has adhered to a set of simple yet insightful values established by our founders quality, service and fair dealing. These are the standards of performance by which our leadership and employees are measured. These values have helped establish Kimberly-Clark as a leading-edge global company that produces superior essential products used by families and professionals from all walks of life and cultures around the world. We are currently seeking a Director for Regulatory Affairs/Quality Assurance (QA / RA) within the KC professional (KCP) sector at our Roswell, GA location. POSITION PURPOSE: Responsible to develop, implement and maintain global KCP quality and regulatory systems. Collaborate with regional and corporate teams to ensure KCP globally meets all quality system and regulatory requirements. Drive improvement in business processes where quality and regulatory involvement is needed, and advance KCP regulatory interests with key internal and external stakeholders. CUSTOMERS AND CUSTOMER REQUIREMENTS: Key customers include consuming customers, sector management, business teams, R&E teams, product supply and quality assurance teams, corporate regulatory affairs and quality assurance teams, external quality and regulatory bodies. Effective performance in this role will require: - Strong collaboration, communication and persuasiveness skills - Credibility with senior leadership internally and regulatory agencies externally - Working effectively across functional and geographic boundaries through influence - Visionary and strategy development skills - Business acumen a clear understanding of the business needs and key imperatives - Experience / aptitude for process re-design and organizational change management - Global breadth of experience and understanding - Quality systems background SCOPE: The Director for Regulatory Affairs/Quality Assurance reports to the Vice President KCP Research and Engineering but will work closely with the Vice President Product Supply and Vice President KC Quality Assurance and Regulatory Affairs. The role supports the KC Professional sector globally. QUALIFICATIONS: - A minimum of a Bachelor's Degree in a relevant field is required. - Requires a minimum of 8-10 years experience in an industry dealing with relevant regulatory requirements and leading regulatory or quality systems implementation and management. - Experience having led or created a team and highly developed leadership capabilities combined with the ability to motivate and lead a diverse team and work in a matrix organization. PREFERRED QUALIFICATIONS: - Knowledge of KCP products, processes, and organization or similar industry experience is preferred - Experience with ISO certification - Experience with global regulations across multiple countries DIMENSIONS: This is a new role for KCP. Regulatory affairs and quality assurance costs are currently rolled into various cost centers throughout the sector. Personnel: Direct reports: This role will initially be an individual contributor. Part of the job accountabilities will be to develop the KCP QA / RA organization. The result of this analysis could possibly pull QA / RA team members currently in other departments into a central organization. Work direction: will provide guidance to sector QA / RA team members. These team members reside in both staff and mill locations. Exact number is not yet determined. PRINCIPLE ACCOUNTABILTIES: - Lead and implement project to improve KCP regulatory capabilities - Complete process assessment for regulatory aspects of new product launches and implement process changes to yield reduced time to market success. - Provide regulatory advice and counsel to support global expansion business strategies. - Ensure ongoing compliance to regulatory and quality system requirements - Identify areas where KCP is at risk in regulatory and quality systems compliance and implement corrective actions - Develop and audit ongoing regulatory and quality systems for compliance, effectiveness and continuous improvement. - Ongoing process owner for KCP quality systems and regulatory processes - Represent and advance KCP regulatory interests with key stakeholders - Direct and prioritize the efforts of global and regional QA / RA teams. - Functional coordination and capability development of KCP global mill level quality teams and external manufacturing partners. - Be an advocate and sponsor for quality and regulatory excellence throughout the global KCP business. - Ensure KCP teams have the correct quality and regulatory capability - Ensure KCP interests are represented with regulatory agencies - Influence test methods, standards and legislation - Develop and Implement global KCP quality and regulatory strategy that provides competitive advantage and improves business results - Develop recommendations for KCP QA / RA strategy, systems and organization - Ensure that his/her career development activities occur in a timely manner. - Contribute to an environment in which all team members are respected, regardless of their individual differences. Be motivated to improve both the individual and team contributions to achieve desired business results.