Regulatory Lead EU
il y a 2 semaines
At BSI, we're seeking a highly skilled Regulatory Lead EU to join our team. As a key member of our Regulatory Services department, you'll play a crucial role in ensuring our conformity assessment activities and certification processes meet the highest standards of regulatory compliance.
Key Responsibilities:- Provide regulatory support to the Head of Notified Body IVDR in establishing and maintaining designations as a Notified Body for applicable Medical Devices Regulations.
- Ensure conformity assessment and certification activities related to the scope of the designations are conducted in compliance with regulatory requirements.
- Support Compliance and Risk, Human Resources, and Legal with processes related to legal status, organizational structure, independence, and impartiality.
- Collaborate with Designating Authorities and participate in coordination activities.
- Support Global Quality and Accreditation in maintaining accreditation.
- Thorough knowledge of Medical Devices Regulations and related Guidance documents.
- Experience in Medical Device Industry, including Quality Management System processes and R&D – Product Development and Manufacturing processes.
- Strong analytical and problem-solving skills, with the ability to interpret legislation and input to policy.
- Excellent communication and influencing skills, with the ability to build relationships with authorities and clients.
- Ability to operate with horizontal and vertical reporting lines.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
We're an equal opportunities employer and welcome applications from diverse candidates. If you're passionate about regulatory compliance and want to make a difference in the Medical Devices industry, we'd love to hear from you.
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