Job Description Summary

Join us at our worldwide headquarters in Pont de Claix as Associate Director for Sustaining Engineering Activities and Customer Excellence, where you’ll lead regulatory initiatives for marketed products and ensure world-class customer support. In this pivotal role, you'll drive dossier maintenance, global expansion, and regulatory compliance while fostering collaboration with cross-functional teams including Regulatory Affairs, R&D, and Quality Engineering. We are looking for a forward-thinking leader with a background in regulatory affairs and customer-facing roles in the pharmaceutical or medical device sectors—ideally with experience in drug-device combination products. The ideal candidate combines strategic vision with hands-on expertise in submission dossiers and regulatory authority interactions, supported by a solid foundation in life sciences or a technical field. Strong communication, project management, and negotiation skills, along with deep knowledge of U.S. medical device regulations, will set you up for success in this high-impact, globally focused role. Ready to lead change and elevate regulatory excellence? This is your moment.

Job Description

BD Medical - Pharmaceutical Systems PS provides industry-leading needle technologies, prefillable syringes, safety and shielding systems, and self-injection systems for pharmaceutical and biotech companies across the globe. The teams offer an extensive selection of solutions designed to protect, package and deliver drug therapies. Billions of products are manufactured by our 7 global factories each year.

We are seeking a leader with experience in regulatory affairs and customer facing (business orientation) within the pharmaceutical and medical device industries, ideally with expertise in drug-device combination products.

YOUR MAIN RESPONSABILITIES :

• Built and lead the team ensuring the right balance between support and empowerment as well as the right level of development and coaching to support cultural change and position RA team as solution providers.

• Own all the regulatory activities across platform for the products already on the market to ensure the appropriate level of compliance and customer support. You will be responsible for identifying valuable trends and insights that will benefit the current business and support the long-term goals of the PS strategy.

• Own all the customer excellence activities and responsible to ensure the appropriate customer support across the direct product and regions as well as extract the value for the business.

• Own promotional material review activities and business specific procedures if relevant. Accountable for alignment of PS external communication & claims to regulatory requirements.

• Educate/Train the PS cross-functional teams on EU and FDA requirements applicable both to pharmaceutical systems and our customers, on an ongoing basis, to ensure current and future associates understand the regulatory framework and environment.

• Accountable for the appropriate registrations with the Competent Authorities as well as regular updates when required. Develop response strategies for regulatory questions and prepare team for interacting and negotiating with regulatory agencies if necessary.

ABOUT YOU:

•  Experienced leader in senior manager role in regulatory affairs with business acumen.

• Background in pharma, medical devices, and ideally drug-device combinations.

• Strong submission dossier preparation and regulatory authority interactions.

• Deep knowledge of U.S. regulations, GxPs, and Quality System Regulation.

• Skilled in regulatory strategy and dossier maintenance.

• Navigates well in matrix organizations and cross-functional environments.

• Values continuous improvement and drives change.

•  Proven people leader with servant and inspirational leadership style

• Effective project manager and communicator.

Click on apply if this sounds like you!

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.

To learn more about BD visit: https://bd.com/careers

--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 amaker of possible with us!

Required Skills

Optional Skills

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Primary Work Location

FRA Le Pont-de-Claix Cedex

Additional Locations

Work Shift

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 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 € - 165 200,00 € EUR Annual