Associate Director, Regulatory Affairs

San Diego, CA, United States

Job Description Summary

Job Description

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.

Key responsibilities will include:

Responsible for the global regulatory strategy for BDB products.

Coordinates and advises the preparation of complex regulatory submissions, including Premarket (510(k)) Notifications, de novo applications, EU Technical Files for CE mark (IVDD/IVDR, and Machinery Directive), pre-Submission documentation, Premarket Approval Applications (PMA), laser reports, WHO pre-qualification submissions, and materials required for registration of products outside the U.S. and EU

Serves as primary regulatory body liaison including interactions with FDA, Notified Body and health ministry outside of US and EU (as required), managing audits, responses, and new submissions, and RA leadership team representative.

Organizes and leads meetings with regulators, including development of agendas, preparation of materials, and training/preparation of company personnel attending the meetings.

Contributes to the development of BDB strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs.

Ensures functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of BDB products with desired claims.

Provides a high degree of regulatory expertise and experience to BDB’s new product development programs, serving as a Core Team advisor and champion for BDB’s Global Product Development System (GPDS)

Leads the RA function on complex, cross-functional project teams; establishes appropriate communication within RA and other functions at project and upper management levels.

Leads and manages risk evaluation and mitigation recommendations to project teams; develops and documents sound regulatory decisions and justifications for BDB products, and process changes.

Ensure product development and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.

Ensures project team and business objectives and deliverables are aligned with regulatory strategy and submission timelines.

Orchestrates the format and information in the development and execution of regulatory submissions.

Serves as a regulatory expert for labeling and promotional materials review, experimental designs, and data analysis as they relate to registration and commercialization of IVDs, and research use only products.

Coordinates with Quality function on compliance activities and responses to quality audit findings

Participates when needed in activities associated with Field Corrective Action (FCA) reviews by the FAC committee and supports regulatory and notified body inspections. This includes routine interaction with Regulatory Compliance personnel.

Monitors and interprets applicable standards, regulations, and directives to ensure Regulatory compliance.

Communicates new developments in worldwide regulations affecting BDB products, provides trends, interpretations and impact assessment to BDB stakeholders.

Participate in Regulatory advocacy activities as required to shape policies, guidance, and standards that are of strategic importance to BDB.

Develop, review and support maintenance of regulatory SOPs.

Manages complex, long-term projects supporting the business and quality objectives of the organization. Projects can be cross-functional and cross-site.

Manages employees, including hiring, performance evaluations and coaching.

Demonstrated strong leadership, project management, organization, and oral and written communication skills.

As appropriate, manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction.

Lead by providing the motivation and inspiration to work effectively toward organizational goals and the individual objectives for reaching the goal.

As appropriate, provide direction, manage activities, and participate in development plans with Regulatory Affairs Staff.

Effectively deploys appropriate management ‘standard processes’ to ensure a team of dedicated, engaged and efficient RA associates.

Instills a culture of continuous improvement by identifying and implementing improvements to support and achieve functional excellence.

Minimum Qualifications:

Bachelor’s degree required with a master’s degree preferred in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.)

RAC Certification a plus.

Minimum of 5 years of direct management experience is required; remote management experience a plus.

Minimum of 10 years’ experience working in an U.S. FDA/or ISO regulated environment and medical device industry.

EU MDR/IVDR experience.

History of successful 510(k) clearances and/or PMA approvals of in vitro diagnostic devices is a plus.

Flow cytometer experience a plus.

Premarket Experience: Experience supporting medical device regulatory submissions; proven experience with application of quality and regulatory requirements for IVD manufacturers in the design and development of medical devices. listings, establishment registrations, etc. is a must.

Proven knowledge of international regulations for product registration. Experience in preparation of EU Technical Dossier, STED documentation, etc.

Excellent project management, negotiation, communication (written and verbal) and interpersonal skills; ability to communicate and work in a diverse team environment; effective interactions with technical personnel (scientific and legal).

Excellent team skills with ability to influence others with and without authority.

Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.

Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.

Ability to identify areas of concern in moderately complex projects and lead changes.

Demonstrated organizational and planning skills, including process savvy, committed, focused urgency and working towards results.

Ability to write high quality submission documentation.

Experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.

Computer literacy (SAP, Microsoft Word / Excel / PowerPoint).

Detail oriented, with emphasis on accuracy and completeness.

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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visithttps://bd.com/careers

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.

PDN

Primary Work Location

USA CA - Milpitas 155

Additional Locations

USA CA - San Diego (BDB)

Work Shift

NA (United States of America)

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.

We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$174,200.00 - $287,400.00

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