Director / Associate Director Regulatory Affairs

3 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.

  • Director / Associate Director Regulatory Affairs

    5 days ago

    United Kingdom Meet Recruitment Limited Full time €80,000 - €120,000

    Director / Associate Director Regulatory Affairs 2 days ago Be among the first 25 applicants 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...

  • Director / Associate Director Regulatory Affairs

    3 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Director / Associate Director Regulatory Affairs 2 days ago Be among the first 25 applicants 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...

  • Director / Associate Director Regulatory Affairs

    3 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....

  • Director / Associate Director Regulatory Affairs

    3 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...

  • Director / Associate Director Regulatory Affairs

    3 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...

  • Associate Regulatory Affairs Director

    5 days ago

    United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) Global Regulatory Affairs, Associate Director (Oncology) United Kingdom - Cambridge, United Kingdom - Uxbridge Regulatory Regular Job Description For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that...

  • Associate Regulatory Affairs Director

    2 weeks ago

    United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) Global Regulatory Affairs, Associate Director (Oncology) United Kingdom - Cambridge, United Kingdom - Uxbridge Regulatory Regular Job Description For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that...

  • Director/Associate Director | Compliance

    5 days ago

    United Kingdom Meet Recruitment Limited Full time €80,000 - €120,000

    Director / Associate Director Regulatory Affairs 2 days ago Be among the first 25 applicants 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...

  • Director/Associate Director | Compliance

    3 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Director / Associate Director Regulatory Affairs 2 days ago Be among the first 25 applicants 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...

  • Director/Associate Director | Compliance

    3 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....

  • Director/Associate Director | Compliance

    3 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....

  • Associate Director/ Director

    5 days ago

    United Kingdom Autolus Ltd Full time

    Vacancy for Associate Director/ Director - Medical Writing Regulatory Affairs Location: UK - White City, West London & Hybrid Job Summary Role Summary With an expanding regulatory team, an exciting opportunity has arisen for an Associate Director or a Director to join the Autolus Regulatory and Medical Writing team to support global expansion of our...

  • Associate Director/ Director

    1 month ago

    United Kingdom Autolus Ltd Full time

    Vacancy for Associate Director/ Director - Medical Writing Regulatory Affairs Location: UK - White City, West London & Hybrid Job Summary Role Summary With an expanding regulatory team, an exciting opportunity has arisen for an Associate Director or a Director to join the Autolus Regulatory and Medical Writing team to support global expansion of our...

  • (Senior) Director Regulatory Affairs CMC

    3 weeks ago

    United Kingdom Autolus Ltd Full time

    Vacancy for (Senior) Director Regulatory Affairs CMC Location: United Kingdom Job Summary Role Summary An exciting opportunity has arisen for an experienced CMC Regulatory Affairs Sr. Director to join the Autolus team to take a leadership role for developing global CMC regulatory strategies and content plans for products across Autolus’ cell and gene...

  • Senior Director Regulatory Affairs

    7 days ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at...

  • Senior Director Regulatory Affairs

    5 days ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...

  • Senior Director Regulatory Affairs

    7 days ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...

  • Senior Director Regulatory Affairs

    7 days ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...

  • Senior Director Regulatory Affairs

    5 days ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...

  • Senior Director/ Executive Director Regulatory Affairs Lead

    3 weeks ago

    United Kingdom Autolus Ltd Full time

    Vacancy for Senior Director/ Executive Director Regulatory Affairs Lead - Autoimmune Location: UK/EU/US Job Summary Role Summary With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Global Regulatory Affairs Lead (Senior Director/Executive Director) for AutoImmune to join the Autolus team to expand their...