Regulatory and Clinical Project Manager

2 weeks ago


High Wycombe, United Kingdom Harris Lord Recruitment Full time
Job Description

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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