Job Title: Regulatory Affairs Project Lead
Industry: Medical Devices
Job Type: Permanent
This is a fantastic opportunity to work as a Regulatory Affairs Project Lead for an internationally recognised leader in the medical devices arena and to work on Class III Medical Devices.
Our client have been established for over 30 years and are a provider of an exciting range of products and services to healthcare providers and patients focusing on reconstruction, theatre accessories and infection control. Our client have grown to become a renowned leader within these markets.
Looking for an exciting and rewarding career? This is a great time to start with our client as a Regulatory Affairs Project Lead, joining an experienced and dynamic team of Regulatory and Quality professionals at a key time.
The company and the RAQA department is in the middle of exciting developments and new projects as the company expand their product portfolio internationally across numerous markets.
The company continue to enjoy year on year growth.
Looking to advance your career? The Regulatory Affairs Project Lead position offers a great opportunity to work in line with international markets, standards and regulations for Class III medical devices.
The company provide comprehensive inductions, training and development programmes to kick on and take your career to the next stage.
Duties and Responsibilities of the Regulatory Affairs Project Lead:
- Lead the provision of regulatory affairs/ QMS compliance into product development and regulatory change projects.
- Provide leadership in projects by providing regulatory requirements and support for projects.
- Support the creation and maintenance of all technical files, DHFs and DMRs
- Support the Regulatory Affairs Training and Awareness program
- Support the performing of internal quality audits including managing CAPAs
- Assess the impact of global regulatory changes on the products and Quality Management Systems- and support the management of the training and awareness program to provide enhanced knowledge of regulatory and QMS requirements
- Support the Group RA/QMS Manager during 2nd & 3rd Party audits/inspections.
Regulatory Affairs Project Lead Experience and Knowledge Required:
- Bachelor Degree in science or engineering or equivalent
- 3+ years' experience required in similar position
- A good understanding of MDD, ISO 13485 and QSR
- Experience of creating 510K files and Design Dossiers
- Training in Quality related fields is desirable
- Experience of sterilization will be advantageous
- Auditor certification is desirable
Interviews available immediately! Get in touch ASAP
Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.
We are dedicated to finding the right opportunity for you.