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Regulatory Affairs Specialist
hace 3 semanas
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
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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
