Regulatory Affairs Team Lead

2 weeks ago

Glasgow, United Kingdom FPSG Full time

**Team Lead Regulatory Affairs**

**Glasgow - Medical Devices**

**Job Profile**

FPSG Life Sciences is working with a leading medical device company looking to recruit a Team Lead in Medical Affairs. Due to continued growth they are expanding their regulatory Affairs team.

**Key Duties**:

- Preparation of Regulatory Documentation: Lead the preparation and submission of regulatory documentation and compliance with relevant regulations and standards.
- Development of Regulatory Plans/Strategies: Develop and implement regulatory plans and strategies for new product development projects and changes to existing products, collaborating closely with cross-functional teams to ensure alignment with business objectives and regulatory requirements.
- Participation in Design Control and Risk Management Activities: Participate in Design Control and Risk Management activities throughout the product lifecycle, ensuring regulatory requirements are addressed and mitigated appropriately to support product safety and efficacy.
- Production and Review of Design Dossiers and Technical Files: Oversee the production and review of design dossiers, technical files, and change assessments
- Regulatory Compliance Monitoring: Stay abreast of regulatory developments and changes in the medical device industry, monitoring changes to regulations, standards, and guidelines

**Qualifications**:

- Bachelor's degree in a scientific or discipline;
- Minimum of 4 years of experience in regulatory affairs within the regulatory scientific industry
- Demonstrated expertise in developing and executing regulatory strategies for new product development and changes to existing products.
- Excellent leadership and interpersonal skills, with the ability to lead and motivate cross-functional teams and drive results in a matrixed environment.
- Exceptional written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.
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