Are you an accomplished Regulatory or Quality Professional? Do you have experience of working with pharmaceuticals and/or medical devices? Are you looking for a challenging, rewarding career with an innovative company?
An innovative development company who specialise in novel inhalation technologies with medical and therapeutic applications are seeking a Regulatory Affairs Manager to join the team. The Regulatory Affairs Manager will play a key role in supporting all regulatory activities of the business.
• Play a key role in the regulatory activities of the company.
• Work with the Chief Regulatory Officer to prepare Market Authorisation Applications and Medical Device Technical Files.
• Work closely with the Quality Department to ensure internal regulatory compliance including drafting and reviewing procedures and policies.
• Support the company in ensuring adherence to GCP in clinical studies.
• Provide regulatory advice and guidance to support R&D.
• Educated to degree level or above in a relevant scientific discipline.
• Experience in a Quality/Regulatory Role within Pharmaceuticals and/or Medical Devices.
• Strong working knowledge of a range of relevant regulations and standards such as GMP, GCP and ISO13485.
• Excellent communication skills.
In return you will benefit from a competitive salary and benefits package and work within a supportive and talented team. This is an excellent time to join this highly innovative company, with fantastic growth and development opportunities for a motivated and ambitious candidate.
This is a full time, permanent role, offering flexible, partly remote working.Apply
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