BD (Tissuemed Ltd)
the makers of possible!
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Position Overview Director of Regulatory Affairs is responsible for developing and implementing regulatory strategies with the Senior Director, Regulatory Management, WW IPD (“Sr Director Regulatory WWIPD”) and submissions in support of global marketing of company products for Infusion Sets. This role reports to the Senior Director, Regulatory Management, WW IPD. The Director provides cross‑functional support and leadership to regulatory teams located in San Diego and Franklin Lakes in concert with final decision making in Switzerland. External contacts include U.S. and international regulatory authorities, physician advisors, and key industry specialists.
Responsibilities
Drive continuous improvement initiatives and develop, under the oversight of the Sr Director Regulatory WWIPD, regulatory strategies to enhance product quality design, regulatory compliance and customer satisfaction.
Ensure a system‑level approach for outside‑of‑the‑U.S. infusion disposable sets, ensuring alignment and consistency in regulatory strategy, communication with regulatory bodies and change‑control determination.
Act as the interface on behalf of the Sr Director Regulatory WWIPD between Worldwide IPD and MMS for design regulatory continuity.
Lead multi‑departmental and business unit teams to implement regulatory strategies set by the Sr Director Regulatory WWIPD, including collection, documentation, analysis and reporting of information for inclusion in worldwide submissions.
Support members of the WW IPD Regulatory Leadership Team.
Ensure product labeling, promotional claims and advertisements comply with U.S. and international laws and regulations.
Manage the Regulatory Affairs platform and lead a team of Regulatory professionals in the U.S., aligning with the mission and vision set by the Sr Director Regulatory WWIPD.
Support change‑control processes and provide problem‑solving expertise to mitigate risks.
Maintain knowledge of current and emerging policies, practices, trends, technology and information affecting the business.
Manage the role’s subordinate team members (less senior managers and/or experienced professionals in the U.S.).
Partner proactively in product development design to provide strategic guidance from exploratory phases through commercialized phases in concert with recommendations from the Sr Director Regulatory WWIPD.
Anticipate detailed regulatory expectations for approval, including precedents and changes in the regulatory landscape.
Serve as a subject‑matter expert on corporate initiatives in support of executive leadership team initiatives.
Prepare, coordinate and manage regulatory audits such as 510(k) audits, ensuring timely responses to questions, non‑conformities or otherwise.
Build relationships with key advocates, regulators and stakeholders to ensure BD’s point of view is understood and carried forward.
Act as a subject‑matter expert at the site and functional level.
Interpret medical device testing methods and statistics, as applicable.
Qualifications
Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering or a medical‑related field.
Successful track record with U.S. and global regulatory bodies.
Minimum of nine (9) years of regulatory affairs or related experience.
Minimum of four (4) years of managerial experience.
Comprehensive knowledge of United States, European and international regulations and standards covering medical devices.
Demonstrated self‑starter and highly motivated.
Excellent written and verbal communication skills, including ability to communicate across cultures; work with others in a team environment; effective interactions with technical personnel (scientific and legal); and negotiate with regulators.
Orientation for detail work product, with emphasis on accuracy and completeness.
Strong knowledge of design control documents; history files, device history records, QC testing, stability reports, etc.
Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
Strong project coordination, business acumen and negotiation abilities.
Proven management skills of multi‑cultural, multi‑national teams, leading and motivating associates toward shared goals and individual development.
Advanced degree preferred.
RAC certification preferred.
Required Health Requirements For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Compensation $179,200.00 – $322,500.00 USD Annual
Employment Details Seniority Level: Director Employment Type: Full‑time Job Function: Legal Industry: Medical Equipment Manufacturing
Location & Shift Primary Work Location: USA, CA – San Diego TC Bldg C & D Work Shift: NA (United States of America)
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We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Position Overview Director of Regulatory Affairs is responsible for developing and implementing regulatory strategies with the Senior Director, Regulatory Management, WW IPD (“Sr Director Regulatory WWIPD”) and submissions in support of global marketing of company products for Infusion Sets. This role reports to the Senior Director, Regulatory Management, WW IPD. The Director provides cross‑functional support and leadership to regulatory teams located in San Diego and Franklin Lakes in concert with final decision making in Switzerland. External contacts include U.S. and international regulatory authorities, physician advisors, and key industry specialists.
Responsibilities
Drive continuous improvement initiatives and develop, under the oversight of the Sr Director Regulatory WWIPD, regulatory strategies to enhance product quality design, regulatory compliance and customer satisfaction.
Ensure a system‑level approach for outside‑of‑the‑U.S. infusion disposable sets, ensuring alignment and consistency in regulatory strategy, communication with regulatory bodies and change‑control determination.
Act as the interface on behalf of the Sr Director Regulatory WWIPD between Worldwide IPD and MMS for design regulatory continuity.
Lead multi‑departmental and business unit teams to implement regulatory strategies set by the Sr Director Regulatory WWIPD, including collection, documentation, analysis and reporting of information for inclusion in worldwide submissions.
Support members of the WW IPD Regulatory Leadership Team.
Ensure product labeling, promotional claims and advertisements comply with U.S. and international laws and regulations.
Manage the Regulatory Affairs platform and lead a team of Regulatory professionals in the U.S., aligning with the mission and vision set by the Sr Director Regulatory WWIPD.
Support change‑control processes and provide problem‑solving expertise to mitigate risks.
Maintain knowledge of current and emerging policies, practices, trends, technology and information affecting the business.
Manage the role’s subordinate team members (less senior managers and/or experienced professionals in the U.S.).
Partner proactively in product development design to provide strategic guidance from exploratory phases through commercialized phases in concert with recommendations from the Sr Director Regulatory WWIPD.
Anticipate detailed regulatory expectations for approval, including precedents and changes in the regulatory landscape.
Serve as a subject‑matter expert on corporate initiatives in support of executive leadership team initiatives.
Prepare, coordinate and manage regulatory audits such as 510(k) audits, ensuring timely responses to questions, non‑conformities or otherwise.
Build relationships with key advocates, regulators and stakeholders to ensure BD’s point of view is understood and carried forward.
Act as a subject‑matter expert at the site and functional level.
Interpret medical device testing methods and statistics, as applicable.
Qualifications
Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering or a medical‑related field.
Successful track record with U.S. and global regulatory bodies.
Minimum of nine (9) years of regulatory affairs or related experience.
Minimum of four (4) years of managerial experience.
Comprehensive knowledge of United States, European and international regulations and standards covering medical devices.
Demonstrated self‑starter and highly motivated.
Excellent written and verbal communication skills, including ability to communicate across cultures; work with others in a team environment; effective interactions with technical personnel (scientific and legal); and negotiate with regulators.
Orientation for detail work product, with emphasis on accuracy and completeness.
Strong knowledge of design control documents; history files, device history records, QC testing, stability reports, etc.
Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
Strong project coordination, business acumen and negotiation abilities.
Proven management skills of multi‑cultural, multi‑national teams, leading and motivating associates toward shared goals and individual development.
Advanced degree preferred.
RAC certification preferred.
Required Health Requirements For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Compensation $179,200.00 – $322,500.00 USD Annual
Employment Details Seniority Level: Director Employment Type: Full‑time Job Function: Legal Industry: Medical Equipment Manufacturing
Location & Shift Primary Work Location: USA, CA – San Diego TC Bldg C & D Work Shift: NA (United States of America)
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