Regulatory and Clinical Project Manager
2 weeks ago
Job Title: Regulatory and Clinical Project Manager
Job Type: Full-time
Location: Remote (Hybrid)
Job Category: Medical Device
About Us: Harris Lord Recruitment is a leading recruitment agency specializing in the medical device industry.
Job Summary:
We are seeking an experienced Regulatory and Clinical Project Manager to join our team. As a key member of our organization, you will be responsible for leading regulatory and clinical projects, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.
Key Responsibilities:
- Lead regulatory and clinical projects, including MDR submissions, new product introductions, and foreign market registrations.
- Maintain Medical Device Files and support regulatory audits.
- Provide guidance to cross-functional teams on regulatory compliance and clinical matters.
- Collaborate with external consultants and conduct literature reviews.
- Prepare regulatory documents, including Clinical Evaluation and Post Market Surveillance Reports.
Requirements:
- Minimum 4 years of experience in a Regulatory & Clinical setting within the medical device industry.
- Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
- PRINCE2 or another recognized project management qualification.
- Proficient in scientific and medical writing, particularly in Clinical Evaluation Reports (CER).
- In-depth understanding of clinical evaluation guidelines and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.
- Proven experience in line management and task delegation.
What We Offer:
- A dynamic and innovative work environment.
- Ongoing training and development programs to enhance your skills and knowledge.
- A clear path for career advancement and opportunities to lead high-profile projects.
- A competitive salary and benefits package.
How to Apply: If you are a motivated and experienced Regulatory and Clinical Project Manager looking for a new challenge, please submit your application.
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