Director / Associate Director Regulatory Affairs

2 weeks ago

United Kingdom Meet Full time

Associate Director (Regulatory Affairs)


My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs.


Title: Associate Director (Regulatory Affairs)

Location: 2-3 Day on-site

Type: Full-time


Key Responsibilities

  • Lead and oversee regulatory affairs activities related to Medical Device Regulation (MDR) compliance.
  • Guide the company through the MDR transition process for Medical Device Class IIa or above products.
  • Manage a team of regulatory affairs professionals, providing mentorship and leadership.
  • Ensure timely submissions and approvals for regulatory filings and compliance documentation.
  • Collaborate cross-functionally with R&D, Quality Assurance, and Clinical teams to support product development and regulatory strategies.
  • Stay updated on regulatory changes and requirements to ensure company compliance.


Qualifications and Experience

  • Bachelor's degree in a related scientific or technical field; advanced degree preferred.
  • Minimum 8 years of experience in regulatory affairs within the medical technology industry.
  • Proven success in leading Medical Device Class IIa or above products through the MDR process.
  • Strong knowledge of European regulatory requirements and standards (MDR, ISO 13485, etc.).
  • Experience managing a regulatory affairs team is desirable.
  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
  • Strategic thinker with the ability to influence decision-making at the executive level.


Benefits

  • Competitive salary and benefits package.
  • Opportunity to work in a collaborative and innovative environment.
  • Direct involvement in shaping the regulatory strategy of a growing medical technology company.
  • Reporting directly to the co-owners of the business, providing significant status and influence within the organization.


If you are a proactive and driven regulatory affairs professional looking for an exciting opportunity to lead MDR compliance efforts and contribute to the growth of a cutting-edge medical technology company, we encourage you to apply.

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