Regulatory Affairs Specialist

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Vectura Group plc Full time
Job Summary
Vectura Group plc is seeking a highly skilled Regulatory Affairs Specialist to lead our medical device regulatory activities. This role involves assuming the role of Regulatory Affairs Manager with specialized expertise in medical devices and drug-device combination products (DDCPs).

About Vectura Group plc
We are a global leader in developing innovative inhaled therapies and drug-device combination products (DDCPs). Our team is dedicated to achieving excellence in patient care through cutting-edge medical technology.

Responsibilities
This position requires strong leadership skills to drive the success of our medical device and DDCP regulatory activities. Key responsibilities include:
  1. Regulatory Leadership: Assume the role of Regulatory Affairs Manager with specialized expertise in medical devices and DDCPs.
  2. Submission & Compliance: Contribute to the regulatory strategy and execution of global regulatory submissions in accordance with the Medical Device Directive (MDD) and Medical Device Regulations (MDR).
  3. Cross-Functional Collaboration: Collaborate effectively with teams in regulatory, quality assurance, and device engineering to ensure seamless regulatory support and compliance throughout product development and commercialization.

Qualifications & Experience
To be successful in this role, you will need:
  1. Proven experience in Regulatory Affairs, particularly in medical devices and drug-device combination products (DDCPs).
  2. In-depth knowledge of MDD, MDR, ISO standards, FDA regulations, and other relevant global regulatory frameworks.
  3. Experience authoring MDR Technical Files, Design Dossiers, and other regulatory submissions.

Salary
The estimated salary for this role is $120,000 - $180,000 per year, depending on location and experience.

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