Regulatory Associate & Senior Regulatory Associate
Medical Devices; Anaesthesia, Suction & Oxygen Therapy & Airway Management
Regulatory Affairs; technical files, global registrations, post market surveillance, labelling, UDI
Office Based – Abingdon, Oxfordshire
Penlon Ltd, a world renowned medical device company with a strong legacy of innovation and global reach, has a great opportunity for 2 Regulatory professionals to join our QA/RA team. 2017 is a year of significant growth through exciting new product introductions and we are looking to strengthen our Regulatory Affairs competences to support these new developments, as well as maintaining our existing product files with latest regulations and applicable standards.
Penlon QA / RA has a commitment to the ongoing professional development of their team through education and mentoring. The Penlon QA / RA team work diversely across multi-functional departments, liaising with our network of QARA professionals, our trade associations, clinical care-givers, global distributors, government bodies and ministries of health. As an SME, the successful candidates will be responsible for delivery of specific projects and report directly to the Director QARA.
The Regulatory Affairs Associate and the Snr Regulatory Affairs Associates are responsible for preparing, submitting and following up on initial and amended technical files to Notified Bodies and/or global Competent Authorities and any other central submissions required in the country(s). You will be responsible to work within agreed project timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval under MDD, MDR, Canada, US FDA, China CFDA & Brazil. The role would include but not limited to the approval of engineering changes specific to product, technical files, 510k;s, UDI, labelling, post market surveillance, vigilance activities and working within project teams.
Get in touch
If you are interested and think this is the right opportunity for you, please email your current cv and a covering letter to:
Please note that we only use pre-approved recruitment agencies and do not accept unsolicited candidate details. If you wish to be considered as a potential recruiter please contact our Human Resources department.