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Senior Regulatory Compliance Officer
2 months ago
About the Job:
The Regulatory Affairs Manager will play a critical role in shaping the company's regulatory strategy and ensuring compliance with relevant regulations. This is a challenging yet rewarding opportunity for a motivated and experienced professional to lead our team and drive business growth.
Key Responsibilities:
- Develop and maintain a comprehensive understanding of EU-MDR and FDA regulations, identifying areas for improvement and implementing changes to ensure compliance.
- Lead the company's transition to EU-MDR requirements, coordinating with cross-functional teams to ensure a smooth transition.
- Manage a team of UK staff, providing training and development opportunities to enhance their skills and knowledge.
- Collaborate with internal stakeholders to develop and implement regulatory strategies, ensuring alignment with business objectives.
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.
Salary: The estimated salary for this role is £90,000 - £120,000 per annum, depending on experience.