Position Summary
The Regulatory Affairs Manager is responsible for overseeing regulatory compliance, submissions, and strategies for medical devices. This role involves leading the company's transition to EU-MDR requirements, managing a team of UK staff, and serving as a deputy Person Responsible for Regulatory Compliance (PRRC).
Key Responsibilities
1. Develop and maintain regulatory knowledge of European, FDA, and country-specific regulations
2. Lead company transition to EU-MDR requirements
3. Coordinate and prepare regulatory submissions and strategies
4. Manage a team of UK staff
5. Act as deputy PRRC, including:
1. Developing continuous improvement processes for product quality and regulatory compliance
2. Preparing and maintaining technical documentation and EU Declaration of Conformity
3. Meeting post-market surveillance obligations
6. Identify compliance issues and conduct or direct required investigations
7. Serve as a point of contact for employees on compliance matters
8. Review and modify policies to comply with changing standards and regulations
9. Stay informed about industry trends and assess their impact on organizational processes
Qualifications and Skills
Required:
1. Advanced degree in a relevant field (e.g., Biomedical Engineering, Pharmacy, Life Sciences)
2. Extensive experience in regulatory affairs within the medical device industry
3. In-depth knowledge of EU-MDR and FDA regulations
4. Strong leadership and team management skills
5. Excellent communication and interpersonal skills
6. Ability to interpret and apply complex regulatory requirements
Desired:
1. Professional certification in Regulatory Affairs (e.g., RAC)
2. Experience with quality management systems
3. Knowledge of international regulatory environments beyond EU and US
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