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Head of Regulatory Affairs

2 months ago

Cambridge Cambridgeshire, United Kingdom BioTalent Full time

Job Title: Head of Quality Assurance and Regulatory Affairs

Location: Hybrid

About Us:

This company is at the forefront of the personalized medicine revolution. They are a dynamic and innovative company dedicated to optimizing the treatment of chronic diseases through a unique approach that combines precision medicine, digital health, and data analytics.

Position Overview:

I am seeking an experienced and highly motivated Head of Quality Assurance and Regulatory Affairs to join the growing team. This key leadership role will be responsible for developing and executing regulatory strategies that ensure the successful approval and compliance of products in global markets. The ideal candidate will have a proven track record in regulatory affairs within the medical device industry, and a passion for advancing personalized medicine.

Key Responsibilities:

  • Regulatory Strategy Development: Lead the development and implementation of comprehensive regulatory strategies for product approvals in key global markets.
  • Compliance and Risk Management: Ensure all company activities comply with applicable regulatory requirements and standards. Identify and mitigate regulatory risks.
  • Cross-functional Collaboration: Work closely with clinical, R&D, quality, and commercial teams to align regulatory strategies with business objectives.
  • Leadership and Mentorship: You will be leading one QA manager and providing mentorship and professional development opportunities.
  • Regulatory Agency Interaction: Serve as the primary point of contact with regulatory agencies, managing communications and negotiations to support product approvals and lifecycle management.
  • Documentation and Reporting: Maintain accurate and detailed records of regulatory activities and prepare comprehensive reports for senior management.

Qualifications:

  • Minimum of 5 years of experience in regulatory affairs within the medical device space SaMD is highly desired
  • Proven success in leading regulatory submissions and securing product approvals in multiple global markets.
  • In-depth knowledge of FDA, EMA, and other relevant regulatory agencies’ regulations and guidelines.
  • Strong analytical, strategic thinking, and problem-solving skills.
  • Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization.
  • Demonstrated leadership experience, with a track record of building and managing high-performing teams.
  • Ability to thrive in a fast-paced, dynamic, and innovative environment.

What We Offer:

  • Competitive salary and benefits package.
  • Flexible working arrangements with a hybrid model
  • Ability to work for one month anywhere
  • Opportunity to be part of a cutting-edge company that is transforming healthcare.
  • A collaborative and inclusive work environment that values professional development and career growth.

Application Process:

If interested in this role please click apply and i shall be in touch shortly