Associate Director Regulatory Affairs
il y a 14 heures
Job Description SummaryJoin Our Global Headquarters in Grenoble – Pont-de-Claix as Associate Director – Regulatory Affairs, Sustainable Engineering & Customer Excellence. 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.Your Key ResponsibilitiesBuild, 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 ProfileBackground 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.LocationPrimary Work Location: FRA Le Pont-de-Claix CedexReady to shape the future of global regulatory excellence? Click Apply and turn your expertise into worldwide impact.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. #J-18808-Ljbffr
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Associate Director, Global Regulatory Affairs – MedTech
il y a 17 heures
Le Pont-de-Claix, France 2000 Becton Dickinson France, S.A. Temps pleinA leading global healthcare company in Le Pont-de-Claix is seeking an Associate Director in Regulatory Affairs to manage regulatory submissions and lead a high-performance team. The role requires deep experience in the MedTech or Pharma industries with a focus on regulatory compliance and customer excellence. Candidates should possess strong leadership...
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