BD · 2 months ago
Director, Regulatory Affairs
USA CA - San Diego TC Bldg C&D
Full-time
Onsite
Director/Executive
$179K/yr - $322K/yr
9+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health through innovative solutions. The Director of Regulatory Affairs will develop and implement regulatory strategies to support global marketing of Infusion Sets, providing leadership and cross-functional support to regulatory teams and liaising with regulatory authorities.
Health CareMedical DeviceTechnical Support
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
Responsible for outside of the U.S. Infusion disposable sets to ensure a system-level approach between pumps and sets, including 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 the regulatory strategies set by the Sr Director Regulatory WWIPD, with respect to the collection, documentation, analysis, and reporting of information for inclusion in Worldwide submission
Supports members of the WW IPD Regulatory Leadership Team
Responsible for product labeling, promotional claims, and advertisements to ensure compliance with U.S. and international laws and regulations
Manage Regulatory Affairs platform and leads a team of Regulatory professionals in the US in alignment with the mission and vision set by the Sr Director Regulatory WWIPD
Support change control processes and problem solving expertise to mitigate risks
Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization
Manages the role’s subordinate team members (less senior managers and/or experienced professionals [in the US]). Strategic battle-tested leader, directs operational units. Inspires action, coordinates simultaneous initiatives
Partners proactively in product development design to provide strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products in concert with the commercialized recommendations provided by Sr Director Regulatory WWIPD
Understands and anticipates detailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape
Serves as subject matter expert on corporate initiatives in support of executive leadership team initiatives on behalf of the Sr Director Regulatory WWIPD
Prepares, coordinates, and manages regulatory audits such as 510Ks audits, and ensures timely responses to questions, non-conformities or otherwise
Builds relationships with key advocates, regulators and internal/ external stakeholders to ensure that BD point of view is understood and carried forward
Act as a subject matter expert (SME) at the site and functional level
Ability to interpret medical device testing methods and statistics, as applicable
Qualification
Required
Bachelor's degree or advanced degree in technical area such as biology, chemistry, engineering, or medical-related field
Successful track record with US and global regulatory bodies
Minimum of nine (9) years regulatory affairs or related experience
Minimum of four (4) years 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 culture; work with others in 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 all the Associates towards the shared goals achievement and the individual development
Preferred
Advance degree preferred
RAC certification preferred
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
Company data provided by crunchbase