Senior Regulatory Affairs Specialist, MDS & MMS EMEA
Remote, Multiple Locations
- ID da oferta
- R-549097
- Category
- Regulatory Affairs
- Location
- Multiple Locations
- Region
- EMEA
We are the people who give possibilities purpose
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.
Job Description
Medication Delivery Solutions (MDS)
As a leading manufacturer and supplier of products that are used daily in healthcare, the Medication Delivery Solutions (MDS) team provide a wide range of products for injection and infusion therapy, regional anaesthesia and closed medication management.
Medication Management Solutions (MMS)
With our technical capabilities, the Medication Management Solutions (MMS) team are able to manage multiple systems and our operational capabilities enable us to have medications available when and where needed, reducing inefficiency and waste for nursing and pharmacy teams.
About the role
TheSenior Regulatory Affairs Specialist, MDS and MMS EMEA, is responsible for supporting and driving regulatory activities across multiple projects within the Dispensing and Pharmacy Automation product portfolio, ensuring compliance with applicable regulatory requirements and industry standards.
The role includes reviewing and handling technical documentation, providing regional regulatory guidance, and leading key regulatory initiatives and special projects. Working closely with cross-functional teams, the Senior Regulatory Affairs Specialist supports strategic business objectives and serves as a subject matter expert on EU regulations, legislation, and standards related to non-medical and software-driven devices.
Location: Cairo, Egypt or Barcelona, Spain
Main responsibilities will include:
Lead the preparation, submission, and maintenance of regulatory applications, including wireless type approvals, registrations, renewals, and product variations across the EMEA region.
Interpret and apply complex regulatory requirements, including EU RoHS, EU Battery, EU Machinery Regulations, and country-specific regulations.
Serve as the primary regulatory liaison for key internal stakeholders, including R&D, Quality, Marketing, Legal, and regional Regulatory Affairs teams.
Provide regulatory guidance throughout the product lifecycle, from development and commercialization to post-market activities.
Monitor evolving regulatory requirements and assess their impact on products, processes, and business operations.
Support the development and execution of regulatory strategies for new product launches and product changes.
Review labeling, promotional content, and other product-related materials to ensure regulatory compliance.
Evaluate product modifications, conduct regulatory impact assessments, and recommend appropriate actions.
About you
Bachelor's degree in a scientific, engineering, or technical field such as Biomedical Engineering, Pharmacy, or Life Sciences.
At least 3–5 years of Regulatory Affairs experience within the medical device industry, with exposure to EMEA regulatory requirements.
Strong knowledge of regulations applicable to electrical, non-medical, and computer-based devices within the EMEA region.
Excellent written and verbal communication skills in English.
Proven ability to interpret complex regulations and translate them into practical business solutions.
Strong analytical thinking, problem-solving, and decision-making capabilities.
Ability to work both independently and collaboratively within cross-functional and international teams.
Experience using regulatory submission systems, databases, and document management tools.
Experience reviewing and approving marketing and promotional materials, including AdProm (Advertising & Promotion) review processes, ensuring compliance with applicable regulatory requirements and company policies.
Why Join Us?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
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.
Required Skills
Optional Skills
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Primary Work Location
EGY - CairoAdditional Locations
ESP BarcelonaWork Shift
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