Regulatory Affairs Specialist

Job Description Summary
Responsible for supporting and executing regulatory activities across multiple projects and UCC and Surgery product lines to ensure compliance with industry standards and regulatory requirements. This role involves reviewing and approving advertising and promotional materials, managing regulatory and product related documentation, providing local regulatory support, and leading special projects. The Regulatory Specialist works closely with cross-functional teams to support business initiatives and offer subject matter expertise on EMEA legislation and standards.

Job Description
Responsibilities

• Review and approve advertising and promotional materials to ensure compliance with regulatory legislations, guidelines and company standards.
• Maintain and update the Technical Documentation Repository (including Technical Data Sheet, Instructions for Use,, Declaration of Conformity,…) to ensure timely and accurate records for internal and external needs and requests..
• Address product-specific regulatory queries from local teams to support market access and compliance.
• Lead non-product-specific regulatory projects, Oversee label review and approval processes to ensure alignment with regional and global regulatory standards.
• Collaborate with European distribution center quality teams to provide regulatory input on First Article Inspection and CRAF procedures and processes
• Support regional initiatives for CE marking and other regulatory asks, ensuring products meet all requirements for European market access.
• Serve as a subject matter expert on EU regulations, offering guidance to internal teams on regulatory standards and compliance issues.

Preferred Requirements

• Experience with EMEA regulatory standards and CE mark requirements is strongly preferred.
• Proficiency in managing regulatory documentation, labeling requirements, and documentation repositories. High level of accuracy in reviewing and approving labeling, advertising, and promotional materials.
• Excellent verbal and written communication skills, with the ability to convey regulatory requirements clearly to both technical and non-technical teams. Ability to lead and manage special projects across regulatory and cross-functional teams.
• Skilled at resolving compliance issues and responding to complex regulatory queries. Flexible in adapting to changing regulatory environments, industry standards, and project demands.
• Strong collaborative skills and a proactive approach to support functions and business unit-specific projects
• High proficiency in English written and spoken.

Education And Experience

• Bachelor's degree in Life Sciences, Biomedical Engineering, or a related field (Master's degree preferred).
• 3-5 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or life sciences industries.
• Experience with EMEA regulatory standards and CE mark requirements is strongly preferred.

Salary range f
or the role: €
35.000 to €42.000

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

At 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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Required Skills
Optional Skills

Primary Work Location

ESP San Agustin del Guadalix

Additional Locations

ESP Barcelona

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
€31, €50,850.00 EUR Annual