BD (Becton, Dickinson and Company) Director Regulatory Affairs MMS – Strategy & Advocacy in San Diego, California
Job Description Summary
Reporting to the Vice President, Regulatory Affairs, the Director Regulatory Affairs is responsible for creating strategic engagement opportunities with US regulators and spearheading MMS public policy and advocacy efforts. Works closely with the Sr. Director, Product Development, to create regulatory strategies and objectives for pre-market programs in alignment with business needs, and with the Sr. Director Lifecycle/Process Excellence to ensure change management and compliance activities are aligned with USFDA requirements. Also consults with QA and assists in preparing for inspections/audits from regulatory agencies.
Working closely with the Sr. Director, RA, Product Development to:
create engagement strategies to connect with the FDA submission review team
develop response strategies for regulatory questions received from the FDA
Educates/Trains the MMS cross-functional teams on FDA requirements on an ongoing basis, to ensure current and future associates understand the regulatory framework and environment
Participates in Public Policy and Advocacy efforts in support of the strategic business direction
Represents MMS in external activities benefiting BD including trade associations, professional organizations, and standards development organizations
Work closely with the MMS Quality Leadership to define audit preparedness plan
Engage with the International Infusion Platform to provide guidance on USFDA requirements for new product development and remediation planning activities
Pressure-test regulatory pathways for new products and product modifications;
Identify and communicate potential risks and mitigations associated with regulatory strategies to stakeholders
Prepares MMS team for interacting/negotiating with U.S. regulatory agencies
B.S. or B.A. degree in a technical discipline (e.g., engineering, biology, chemistry). Advanced degree preferred.
Minimum 10 years of direct regulatory agency experience.
Experience with Medical devices, pumping systems and electromechanical devices.
Demonstrated leadership skills.
Demonstrated project management, negotiation, and communication (written and oral) skills.
Comprehensive knowledge of U.S. medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.
Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDMDD 98/79/EC preferred.
Remote role: 25% Travel
Primary Work Location
USA CA - San Diego TC Bldg C&D
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.