Senior Manager QARA

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).

• 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

Required:

• 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

Desired:

• Professional certification in Regulatory Affairs (e.g., RAC)
• Experience with quality management systems
• Knowledge of international regulatory environments beyond EU and US

• Pension Plans
• Work From Home
• Training & Development