Associate Director Regulatory Affairs – Medtech pharma
il y a 6 jours
At BD Medical – Pharmaceutical Systems, we lead the way in advanced drug delivery and injection technologies. We partner with the world's top pharmaceutical and biotechnology companies, delivering billions of devices each year across our seven international manufacturing sites.
In this strategic role based in Grenoble – Pont de Claix, we are seeking an accomplished leader with a strong background in MedTech or Pharma, ideally with medical device expertise and a proven track record in international Regulatory Affairs management—preferably with U.S. exposure. You bring solid experience across pharmaceutical, medical device, and ideally combination product environments, along with deep knowledge of FDA regulations, GxP, and Quality System Regulation.
As an inspiring and culturally agile leader, you will drive regulatory initiatives for our marketed products while ensuring world class customer support. You will be a key leader overseeing regulatory submissions, global expansion, compliance, and cross functional collaboration across Regulatory Affairs, R&D, and Quality.Job Description
Your Key Responsibilities
- Build, mentor, and develop a high‑performing team focused on solutions, agility, and cultural transformation.
- Lead all regulatory activities for marketed products to ensure compliance and exceptional customer support.
- Own customer excellence initiatives, including regional support, customer feedback valorization, and value creation for the business.
- Oversee the review of promotional materials and ensure alignment with regulatory requirements.
- Train cross‑functional teams on European and U.S. (FDA) regulations relevant to our pharmaceutical systems and those of our clients.
- Ensure regulatory registrations with competent authorities are maintained and up to date. Prepare teams for interactions and negotiations with regulatory agencies.
Your Profile
- Background in MedTech or Pharma, ideally with medical device knowledge and strong leadership capabilities.
- Experienced Regulatory Affairs team manager with international exposure—ideally U.S.-based—with both strategic and operational acumen.
- Solid experience in the pharmaceutical, medical device, and ideally combination product (drug–device) industries.
- Proven expertise in regulatory submissions and interactions with competent authorities.
- Deep understanding of U.S. regulations (FDA), GxP, and Quality System Regulation.
- Comfortable navigating matrixed and multicultural environments.
- An inspiring, motivating leader committed to talent development and continuous improvement.
- Strong communication and project management skills.
- English fluent must have, French nice to have.
- Compensation range: €90K–€110K base salary + bonus + BD benefits package.
Ready to shape the future of global regulatory excellence?
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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.
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--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.
--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, 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.
Become a maker of possible with us
Required Skills
Optional Skills
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Primary Work LocationFRA Le Pont-de-Claix CedexAdditional LocationsWork ShiftAt 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 or hourly rate 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 or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.
Salary Range Information
€91 800,00 - €146 850,00 EUR Annual-
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