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Clinical and Regulatory Affairs Specialist

2 months ago

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

Regulatory and Clinical Manager

Job Summary

Harris Lord Life Sciences is seeking a highly skilled Regulatory and Clinical Manager to join our team. As a key member of our organization, you will play a critical role in ensuring the regulatory compliance and clinical effectiveness of our medical devices.

Key Responsibilities

  • Project Management: Lead regulatory and clinical projects, including MDR submissions, new product introductions, and foreign market registrations. Manage CAPAs and maintain project documentation.
  • 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

Requirements

  • Experience: A minimum of 4 years in a Regulatory & Clinical setting within the medical device industry, with a strong focus on technical functions.
  • Education: 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). Able to conduct clinical searches relevant to our products.
  • Regulatory Knowledge: In-depth understanding of clinical evaluation guidelines and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.
  • Leadership: Proven experience in line management and task delegation.

What We Offer

  • Impactful Work: You'll 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.
  • Career Growth: We offer a clear path for career advancement, with opportunities to lead high-profile projects and take on more significant responsibilities within the organisation.
  • Professional Development: You'll have access to 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.
  • Innovative Environment: Work alongside a talented, multidisciplinary team in a company that values creativity, innovation, and continuous improvement.
  • Work-Life Balance: We understand the importance of balance and offer flexible working arrangements to help you manage your professional and personal life effectively.