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Director, Regulatory Affairs
role at
BD .
BD is one of the largest global medical technology companies.
Job Summary The Director of Regulatory Affairs will develop and implement regulatory strategies in support of global marketing of infusion set products, reporting to the Senior Director, Regulatory Management, WW IPD. The role includes cross‑functional leadership, external regulatory interactions, and regulatory audit management.
Responsibilities
Drive continuous improvement initiatives and develop regulatory strategies to enhance product quality, regulatory compliance and customer satisfaction.
Ensure system‑level regulatory approach for U.S. and outside‑U.S. infusion disposable sets, aligning with product design and change control.
Act as interface between Worldwide IPD and MMS for design regulatory continuity.
Lead multi‑departmental teams to implement strategies, manage documentation and reporting for worldwide submission.
Support the World IPD Regulatory Leadership Team.
Ensure product labeling, promotional claims and advertisements comply with U.S. and international laws.
Manage the Regulatory Affairs platform and lead U.S. regulatory professionals.
Support change control processes and provide problem‑solving expertise to mitigate risks.
Maintain knowledge of current and emerging regulatory policies and trends.
Lead subordinate team members, coordinate simultaneous initiatives and inspire action.
Partner proactively in product development design, providing guidance from exploratory phases through commercialization.
Anticipate detailed regulatory expectations for approvals and regulatory landscape changes.
Serve as subject‑matter expert on corporate initiatives for executive leadership.
Prepare, coordinate and manage regulatory audits, including 510(k) audits, and respond to questions and non‑conformities.
Build relationships with regulators and stakeholders to represent BD’s view.
Act as subject‑matter expert at site and functional level.
Interpret medical device testing methods and statistics.
Qualifications
Bachelor’s degree or advanced degree in biology, chemistry, engineering, or other medical related field.
Minimum of nine (9) years regulatory affairs or related experience.
Minimum of four (4) years managerial experience.
Demonstrated track record with U.S. and global regulatory bodies.
Comprehensive knowledge of U.S., European, and international regulations and standards covering medical devices.
Strong project management, coordination, negotiation and business acumen skills.
Excellent written and verbal communication skills, with ability to interact across cultures and technical disciplines.
Orientation for detail and accuracy in work products.
Strong knowledge of design control documents, history files, QC testing and stability reports.
Proven ability to manage multicultural, multi‑national teams and motivate associates toward shared goals.
Advanced degree preferred.
RAC certification preferred.
Additional Information Salary range: $179,200.00 – $322,500.00 USD Annual.
Primary Work Location: USA CA – San Diego, TC Bldg C & D.
Employment type: Full‑time. Seniority level: Not applicable.
COVID‑19: Employment may be contingent upon proof of full vaccination.
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Director, Regulatory Affairs
role at
BD .
BD is one of the largest global medical technology companies.
Job Summary The Director of Regulatory Affairs will develop and implement regulatory strategies in support of global marketing of infusion set products, reporting to the Senior Director, Regulatory Management, WW IPD. The role includes cross‑functional leadership, external regulatory interactions, and regulatory audit management.
Responsibilities
Drive continuous improvement initiatives and develop regulatory strategies to enhance product quality, regulatory compliance and customer satisfaction.
Ensure system‑level regulatory approach for U.S. and outside‑U.S. infusion disposable sets, aligning with product design and change control.
Act as interface between Worldwide IPD and MMS for design regulatory continuity.
Lead multi‑departmental teams to implement strategies, manage documentation and reporting for worldwide submission.
Support the World IPD Regulatory Leadership Team.
Ensure product labeling, promotional claims and advertisements comply with U.S. and international laws.
Manage the Regulatory Affairs platform and lead U.S. regulatory professionals.
Support change control processes and provide problem‑solving expertise to mitigate risks.
Maintain knowledge of current and emerging regulatory policies and trends.
Lead subordinate team members, coordinate simultaneous initiatives and inspire action.
Partner proactively in product development design, providing guidance from exploratory phases through commercialization.
Anticipate detailed regulatory expectations for approvals and regulatory landscape changes.
Serve as subject‑matter expert on corporate initiatives for executive leadership.
Prepare, coordinate and manage regulatory audits, including 510(k) audits, and respond to questions and non‑conformities.
Build relationships with regulators and stakeholders to represent BD’s view.
Act as subject‑matter expert at site and functional level.
Interpret medical device testing methods and statistics.
Qualifications
Bachelor’s degree or advanced degree in biology, chemistry, engineering, or other medical related field.
Minimum of nine (9) years regulatory affairs or related experience.
Minimum of four (4) years managerial experience.
Demonstrated track record with U.S. and global regulatory bodies.
Comprehensive knowledge of U.S., European, and international regulations and standards covering medical devices.
Strong project management, coordination, negotiation and business acumen skills.
Excellent written and verbal communication skills, with ability to interact across cultures and technical disciplines.
Orientation for detail and accuracy in work products.
Strong knowledge of design control documents, history files, QC testing and stability reports.
Proven ability to manage multicultural, multi‑national teams and motivate associates toward shared goals.
Advanced degree preferred.
RAC certification preferred.
Additional Information Salary range: $179,200.00 – $322,500.00 USD Annual.
Primary Work Location: USA CA – San Diego, TC Bldg C & D.
Employment type: Full‑time. Seniority level: Not applicable.
COVID‑19: Employment may be contingent upon proof of full vaccination.
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