Requirements: English
Company: Becton Dickinson AG
Region: Eysins , Vaud
Responsibilities
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 healthTM is our Purpose, and its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
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, youll 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.
Become a maker of possible with us!
Our vision for Regulatory Affairs at BD
The Regulatory Affairs team is helping to ensure speed to market for BDs innovative medical technologies by having an acutely patient-centric mindset.
About the role
As Senior Director Regulatory Affairs, you will lead the Regulatory Affairs function for the WWIPD RA organization. This position is accountable for driving stakeholder engagement, partnering closely with MMS and MDS Leadership Teams to further the WWIPD RA strategy.
This role is responsible for the development and execution of the WWIPD RA strategy in support of the WWIPD strategic initiatives and expected to create and manage effective partnerships with regulators, including applicable Notified Bodies, US FDA, and key market regulators.
Main responsibilities will include:
- Develop the regulatory strategic roadmap and provide regulatory leadership for programs in the pre-market and post-market space for the WWIPD business.
- Provide strategic guidance to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans.
- Serve as a representative of WWIPD and actively contribute to key strategic decisions impacting the development of regulatory policies, standards, and strategies.
- Build and define regulatory pathways for new products; develop regulatory strategies and tactical plans for submissions to regulatory bodies.
- Liaise with global MMS and MDS RA lead(s) to ensure strategic alignment.
- Identify and communicate potential risks and mitigations associated with regulatory strategies to stakeholders.
- Direct and contribute to the preparation and submission of U.S. [510(k)s, IDEs, and PMAs] and International regulatory filings for the business group products in accordance with policies and procedures established by the company and regulatory agencies.
- Direct the preparation of product information for product registrations.
- Incorporate Worldwide regulatory developments affecting the Business Groups Platforms and Programs and communicate emerging opportunities and concerns to stakeholders.
- Ensure that WW ISD product labeling and promotional materials follow Corporate and international regulations and requirements.
- Lead a staff of regulatory professionals responsible for product submission/registration activities.
- In conjunction with RA business partners, provide input into the budget process for Regulatory Affairs.
- Represent the Business in interactions/negotiations with global regulatory agencies and Notified Bodies; engage in external activities benefiting BD including trade associations, professional organizations, and standards development organizations.
About you
You are a skilled regulatory affairs leader with a proven track record in the medical device industry. You bring extensive experience in managing high-risk medical device submissions and have a deep understanding of global regulatory standards. Your strategic approach, outstanding leadership skills, and ability to collaborate across functions set you apart.
- Proficiency in high-risk medical devices, pumping systems, and electromechanical devices.
- Proven success in global regulatory submissions and negotiations.
- Experience in negotiating with global regulatory agencies and Notified Bodies required.
- Strong project management, negotiation, and communication skills.
- Current and comprehensive knowledge of European quality system standards and requirements under the medical device directi