Regulatory Affairs Specialist EMEA - Surgery H/F Becton Dickinson

Job Description Summary
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.

Job Description

Responsibilities

- Collaboratewith EMEAregion, especially RegulatoryAffairs,onregistrationsand provide requested documentationin accordance withdeadlines as agreed with Region RA and manager.

- Build a strong and preferred partnership with the EMEA region, which includes but not limited tobuilding and leadingregular forums andtouch points,communication toolssuch asdashboards, spreadsheets, etc.

- Strategize and identifyappropriate regulatorypathways tofacilitatemarket access or business continuityin accordance withBU Surgeryobjectives, in collaboration with the manager.

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

- Supports international registrations and productreleaseto marketactivitie, 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 asrequired,whichcould include but not limited to:

- Provide regulatory support through the product life cycle on product project teamsfor changes primarilyimpactingthe EMEA registration(e.g., developing regulatory strategies, timeline development, change control and preparing submission relateddocuments)

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

Preferred Requirements:

- Master'sdegree inlife sciences or scientific field(e.g., engineering, biology, chemistry, health science).

- Two(2)or moreyears Regulatory Affairs experience with medical devices or in vitro diagnostic deviceswith knowledge and experience withEMEA registrationsand requirementsfor medical devices, international experience preferred.

- Strongoral and written communications skills; ability to workinmulti-culturalenvironment; 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 responsibilitieswithsolution-oriented mindset.

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

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!

Click on apply if this sounds like you!

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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Primary Work Location
FRA Grenoble

Additional Locations

Work Shift

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Informations sur la fourchette salariale
€36,400.00 - €65,500.00 EUR Annuelle