Job Description Summary

Responsible for supporting and executing regulatory activities across multiple projects and Specimen Management 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

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!

Our vision for Regulatory Affairs at BD

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.

About the role

The Regulatory Specialist plays a key role in ensuring compliance with industry standards and regulatory requirements across multiple projects and Specimen Management product lines. This position involves reviewing and approving advertising and promotional materials, managing technical documentation such as Instructions for Use and Declarations of Conformity, and supporting CE marking initiatives for European market access. Acting as a subject matter expert on EU regulations, the role provides guidance to internal teams and serves as the regulatory point of contact for B2B clients and stakeholders.

In addition to product-specific responsibilities, the Regulatory Specialist leads non-product regulatory projects, oversees label review processes, and collaborates with cross-functional teams to support business initiatives. The role also includes providing regulatory input on distribution center quality processes, supporting partnerships and OEM management, and addressing local regulatory queries to facilitate market access. This position requires strong knowledge of EMEA legislation and the ability to maintain accurate documentation while driving compliance across regional and global standards.

Main responsibilities will include:

• Review and approve advertising and promotional materials to ensure compliance with regulatory legislation, guidelines and company standards.

• Maintain and update the Technical Documentation Repository (including Technical Data Sheet, Instructions for Use, and Declaration of Conformity) to ensure timely, accurate records for internal and external use and requests.

• Address product-specific regulatory queries from local teams to support market access and compliance. Act as the regulatory point of contact for B2B clients and collaborators

• Lead non-product-specific regulatory projects and oversee label review and approval processes to ensure alignment with regional and global regulatory standards. Collaborate with European distribution centre quality teams to provide regulatory input on CRAF procedures and processes.

• Provide support to the BU that is willing to engage in partnerships and joint initiatives, OEM management.

• Support regional initiatives for CE marking and other regulatory asks, ensuring products meet all requirements for European market access and serve as a subject matter expert on EU regulations, offering guidance to internal teams on regulatory standards and compliance issues.

About You

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.

Knowledge and Skills

• Strong understanding of EMEA legislation, standards, and regulatory frameworks, particularly for medical devices, including IVDs, and non-medical products.

• Proficiency in managing regulatory documentation, labeling requirements, and documentation repositories. High level of accuracy in reviewing and approving labeling, advertising, and promotional materials.

• Ability to lead and manage special projects across regulatory and cross-functional teams. Strong collaborative skills and a proactive approach to support functions and business unit-specific projects.

• Excellent verbal and written communication skills, with the ability to convey regulatory requirements clearly to both technical and non-technical teams.

• Skilled at resolving compliance issues and responding to complex regulatory queries. Flexible in adapting to changing regulatory environments, industry standards, and project demands.

• High proficiency in English, written and spoken.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

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

Required Skills

Optional Skills

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Primary Work Location

BEL Erembodegem - Dorp 86

Additional Locations

ESP San Agustin del Guadalix

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

€49,100.00 - €83,500.00 EUR Annual