Regulatory Affairs Specialist EMEA

The Regulatory Affairs Specialist EMEA will drive regulatory strategies and submissions to support compliance and business growth for BD's Interventional Surgery Business Unit in the EMEA region. Reporting to the Regulatory Affairs Manager in Grenoble, France, this on-site role (4 days per week) involves close collaboration with regional RA and marketing teams, ensuring adherence to medical device regulations and facilitating new product introductions aligned with business objectives. The position also provides regulatory support for marketed products and may assist other regions when needed.

Success in this role requires strong communication skills, a business-oriented mindset, and the ability to thrive in a multicultural environment while meeting deadlines and challenging the status quo. Daily interactions will primarily be in English with colleagues across EMEA and the US. BD values on-site collaboration to foster innovation and problem-solving, while maintaining flexibility and work-life balance.

Responsibilities

• Collaborate with EMEA region, especially Regulatory Affairs, on registrations and provide requested documentation in accordance with deadlines as agreed with Region RA and manager.

• Build a strong and preferred partnership with the EMEA region, which includes but not limited to building and leading regular forums and touch points, communication tools such as dashboards, spreadsheets, etc.

• Strategize and identify appropriate regulatory pathways to facilitate market access or business continuity in accordance with BU Surgery objectives, in collaboration with the manager.

• Identify and communicate appropriately quantified risks and mitigations associated with regulatory strategies to cross-functional stakeholders.

• Supports international registrations and product release to market activitie, including regulatory operational support such as updates for regulatory databases such as RIM, and associated work including updates for regulatory releases.

• Perform other duties and assignments as required, which could include but not limited to:

• Provide regulatory support through the product life cycle on product project teams for changes primarily impacting the EMEA registration (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)

• Prepare and update STED technical files for CE marking activities and notified body interactions

Preferred Requirements:

• Master's degree in life sciences or scientific field (e.g., engineering, biology, chemistry, health science).

• Two (2) or more years Regulatory Affairs experience with medical devices or in vitro diagnostic devices with knowledge and experience with EMEA registrations and requirements for medical devices, international experience preferred.

• Strong oral and written communications skills; ability to work in multi-cultural environment; ability to manage several parallel deliverables.

• Excellent organization & prioritization skills with a demonstrated ability to effectively handle multiple project priorities.

• Demonstrated ability to influence others.

• Self-motivated, work independently, and have the ability to take ownership of responsibilities with solution-oriented mindset.

Competitive salary range: €45,000 – €53,000

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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.

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t BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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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FRA Grenoble

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

€36, €65,500.00 EUR Annual