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Regulatory Affairs Manager
2 months ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Harris Lord Life Sciences. As a key member of our Medical Devices department, you will play a critical role in ensuring the regulatory compliance of our products and services.
Key Responsibilities- Lead regulatory and clinical projects, including MDR submissions, new product introductions, and foreign market registrations.
- Maintain Medical Device Files, support regulatory audits, and provide guidance to cross-functional teams.
- Collaborate with external consultants, conduct literature reviews, and prepare regulatory documents like Clinical Evaluation and Post Market Surveillance Reports.
- Develop and implement regulatory strategies to ensure compliance with relevant guidelines and regulations.
- Provide expert advice on regulatory matters to internal stakeholders and external partners.
- A minimum of 4 years of experience in a Regulatory & Clinical setting within the medical device industry, with a strong focus on technical functions.
- Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
- Proven experience in line management and task delegation.
- Excellent writing and communication skills, with the ability to prepare high-quality regulatory documents.
- Strong knowledge of clinical evaluation guidelines and regulations, including MEDDEV 2.
- A competitive salary and benefits package.
- Ongoing training and development opportunities to support your career growth.
- A collaborative and dynamic work environment.
- The opportunity to work on high-profile projects and contribute to the success of our Medical Devices department.