Bard Davol Inc., a subsidiary of C. R. Bard, Inc., located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. We focus our business on key surgical specialties, including Soft Tissue Repair, Surgical Fixation, Biomaterials and Orthopedic/Wound Management Irrigation.
Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.
Davol headquarters is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.
Summary of Position with General Responsibilities
The position of Regulatory Affairs Specialist / Sr. Regulatory Affairs Specialist will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in both the U.S. and global regions. Provide regulatory support to marketed products and ensure company’s regulatory compliance status.
Essential Job Functions
- 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, PMA supplemental applications)
- Support 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, international change notifications).
- 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 application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTED, International Dossier).
- 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.
- Support due diligence and business integration activities as assigned.
- Support the development and implementation of Davol and Bard regulatory processes, procedures, and standards as assigned.
- Special projects as assigned.
- Bachelors of Science required, with emphasis on life science or engineering.
- Regulatory Affairs Specialist: Minimum of three years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers).
- Sr. Regulatory Affairs Specialist: Minimum of five years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers).
- Previous experience in supporting regulatory projects and R&D/Quality teams.
- Solid knowledge in FDA, EU regulations for medical device.
- 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 to travel approximately 10% of time.
Additional Desirable Qualifications Skills and Knowledge
- Professional certifications preferred.
- Advanced Degrees preferred.