Senior Regulatory Compliance Manager
Senior Regulatory Compliance Manager
Eindhoven
Netherlands
Permanent
Medical & Regulatory Affairs
1
Senior Manager, Regulatory ComplianceAbout the Role:
As the Senior Manager, Regulatory Compliance, you will play a pivotal role in leading the Regulatory Team for a medical device company. You will be responsible for defining regulatory pathways, providing expert guidance, and supporting technical teams throughout the product lifecycle. Your primary focus will be ensuring regulatory compliance with applicable standards.Key Responsibilities:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) per MDR Article 1
- Provide crucial regulatory support for developing comprehensive Design History Files and Technical Documentation
- Collaborate with cross-functional teams to offer regulatory guidance on product design, development, evaluation, labeling, and marketing
- Oversee packaging and labeling requirements.
- Create Submission Files in accordance with 21 CFR 820 and the General Safety and Performance Requirements (GSPR) checklist
- Drive and coordinate technical file submissions in EU and other international markets, working with internal teams and external consultants
- Manage worldwide registrations of approved products.
- Continuously assess regulatory activities against newly published guidance related to the Medical Device Regulation (MDR) and standards
- Conduct traceability and compliance assessments to demonstrate adherence to applicable standards (e.g., 14708-1, 14708-3, IEC 60601-1)
- Collaborate on Failure Modes and Effects Analysis (FMEA) in alignment with ISO 14971 requirements
- Participate in ISO audits and support the Quality department in audit preparation.
- Lead, mentor, and manage Regulatory Specialists.
Qualifications:
- Bachelor’s or Master’s degree in Engineering, Quality, or Regulatory field.
- Minimum 7+ years of relevant medical device experience, preferably with Class III devices such as active implantable medical devices.
- Strong understanding of translating standards into compliance/traceability reports.
- In-depth knowledge of quality management systems (ISO 13485) and other relevant standards (ISO 14708-1/-3, ISO 14971, IEC 62304, IEC 60601, ISO 62366, ISO 15223-1).
- Experience with ISO audits.
- High energy, self-motivated, and proactive personality.
- Ability to work effectively in a diverse team within a startup environment.
- Fluency in English (company language). French language proficiency is highly valued.
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.
Ryan Griffin
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