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Regulatory Affairs Manager

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Harris Lord Life Sciences Full time £67,500
Job Description

Regulatory and Clinical Manager

Location: Hybrid (2x a week at home after successful probation)

About the Role:

We are seeking a highly skilled Regulatory and Clinical Manager to join our team at Harris Lord Life Sciences. As a key member of our organization, you will play a critical role in bringing life-changing medical devices to market, ensuring they meet the highest regulatory standards and are backed by robust clinical evidence.

About You:

  • A minimum of 4 years 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.
  • Writing Skills: Proficient in scientific and medical writing, particularly in Clinical Evaluation Reports (CER).
  • Regulatory Knowledge: In-depth understanding of clinical evaluation guidelines and regulations, including MEDDEV 2.
  • Leadership: Proven experience in line management and task delegation.

About the Job:

  • Project Management: Lead regulatory and clinical projects, including MDR submissions, new product introductions, and foreign market registrations.
  • Regulatory Compliance: Maintain Medical Device Files, support regulatory audits, and provide guidance to cross-functional teams.
  • Clinical Oversight: Collaborate with external consultants, conduct literature reviews, and prepare regulatory documents like Clinical Evaluation and Post Market Surveillance Report.

What We Offer:

  • A clear path for career advancement, with opportunities to lead high-profile projects and take on more significant responsibilities within the organization.
  • Ongoing training and development programs, including support for certifications and attendance at industry conferences, to keep you at the forefront of regulatory and clinical expertise.
  • Flexible working arrangements to help you manage your professional and personal life effectively.