Regulatory Affairs Director
3 weeks ago
Job Summary
Stirling Q&R is seeking a highly skilled Regulatory Affairs Manager to lead the company's transition to EU-MDR requirements, manage a team of UK staff, and serve as a deputy Person Responsible for Regulatory Compliance (PRRC). This role involves overseeing regulatory compliance, submissions, and strategies for medical devices.
Key Responsibilities
- Develop and maintain regulatory knowledge of European, FDA, and country-specific regulations.
- Lead company transition to EU-MDR requirements.
- Coordinate and prepare regulatory submissions and strategies.
- Manage a team of UK staff.
- Act as deputy PRRC, including:
- Developing continuous improvement processes for product quality and regulatory compliance.
- Preparing and maintaining technical documentation and EU Declaration of Conformity.
- Meeting post-market surveillance obligations.
- Identify compliance issues and conduct or direct required investigations.
- Serve as a point of contact for employees on compliance matters.
- Review and modify policies to comply with changing standards and regulations.
- Stay informed about industry trends and assess their impact on organizational processes.
Requirements
Qualifications and Skills
- Advanced degree in a relevant field (e.g., Biomedical Engineering, Pharmacy, Life Sciences).
- Extensive experience in regulatory affairs within the medical device industry.
- In-depth knowledge of EU-MDR and FDA regulations.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to interpret and apply complex regulatory requirements.
Benefits
- Pension Plans.
- Work From Home.
- Training & Development.
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