Director, Regulatory Affairs

Becton Dickinson Medical Devices•San Diego, CA

14d

About The Position

We are 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 the 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. 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 made in Switzerland on such support. There will be external contacts with US and international regulatory authorities, physician advisors, and key industry specialists. Knowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization is essential.

Requirements

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

Nice To Haves

Advance degree preferred
RAC certification preferred

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