The position of Regulatory Affairs Specialist will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations. Provide regulatory support to marketed products.
Summary of Position with General Responsibilities:
- Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s).
- Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales).
- Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
- Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD).
- Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
- Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
- Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
- Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
- Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Additional Desirable Qualifications Skills and Knowledge:
- B.S. degree or equivalent with emphasis on Life Sciences. Professional certifications preferred.
- Knowledge and experience 4-6 years with regulatory requirements for medical devices including submission of IDE’s, PMA’s and 510(k)’s, and CE mark technical files.
Professional certifications preferred.
Good oral and written communications skills and ability to work on cross-functional teams.
Working knowledge of statistics and electronic documentation and information systems.
Ability and desire to travel as needed.
C. R. Bard - 2 years ago
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...