Associate Director, Regulatory Affairs

2 weeks ago

Milpitas, United States BD Full time

**Job Description Summary**:
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.
- 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.

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