Senior Regulatory Affairs Specialist
Job Description Summary
Eof This position will be working in the BD Interventional Surgery Business Unit supporting the V Mueller platform. Under the guidance of the Director of Regulatory Affairs, the position will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in U.S. and global regions. Additionally, the position will provide regulatory support to marketed products and ensure company’s regulatory compliance status.
- Coordinate, prepare, and execute US FDA 510(k) submissions to the US FDA and all other applicable global regulatory authorities for class II devices in the V Mueller portfolio.
- Act as liaison with FDA and all global regulatory authorities, as applicable, in support of global submissions.
- Facilitate creation and communication of responses to any requests for information from the FDA and/or other regulatory authorities, related to these submissions.
- Assess necessity for reporting changes to FDA (and other regulatory authorities as applicable) for proposed device modifications.
- Prepare robust justifications for changes that do not require supplements or notices.
- Assist Product Development and Quality Assurance in planning testing that will ultimately be used in regulatory submissions.
- Provide regulatory support on a range of activities which include domestic/international submissions, change assessments, quality system support, post market surveillance, and other compliance activities.
- Collaborate effectively with project teams to identify risks and risk mitigation strategies.
- Coordinate and prepare technical files and/or STEDS for submissions outside the US for new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.).
- Assist in the review and approval product labeling, promotional, and advertising materials to ensure regulatory compliance.
- Review and approve regulatory data provided by private label suppliers to ensure compliance to regulations and to support labeling and advertising activities.
- Bachelor’s Degree required
- 3 – 5 years of technology, engineering, personal care, food manufacturing, or clinical industry experience
- Exposure to regulatory compliance
- Experience working on cross-functional teams
- Science, engineering, or clinical degree preferred
- Experience with new product development preferred
- Experience in the medical device or pharmaceutical industry preferred
- Experience with regulatory bodies preferred
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Job posted: 2020-11-18