Description
SENIOR REGULATORY AFFAIRS ASSOCIATEMy client has been a pioneer in the fields of orthopaedics, spinal care and neuroscience therapies for decades.
From non-surgical pain management to complete surgical solutions, it's range of treatment options include those for treating or reconstructing damaged or diseased joints, caring for traumatic skeletal injuries, treating spinal disorders and deformity, and repairing injured soft tissue.
There is an exciting opportunity for a Senior Regulatory Affairs Associate to join our small but very successful team based in Blackpool. The role includes CE marking and worldwide registrations of medical devices and drug-device combination products, and the chance to participate in global projects. You have the advantage of a supportive, team-oriented environment where your capabilities and potential are recognised and nurtured.
Role overview:
- To manage worldwide product registrations and CE marking activities, to ensure timely and systematic approvals in accordance with regulatory and Company requirements.
- Provide support and advice to company colleagues concerning CE marking and other world regulatory requirements.
- Liaise with internal departments, project teams, worldwide regulatory colleagues and external regulatory bodies to support and co-ordinate timely applications for CE marking and other registration activities.
- Facilitate worldwide product registration activities (including US) by compiling appropriate dossiers, submissions and responses to regulatory bodies.
- Provide input to and regulatory approval for Product Literature, Product and Manufacturing Changes, Design History Files, Risk Assessments, Corrective and Preventative Actions, regulatory audits and vigilance activities.
Qualifications
- To be part of this successful team you will have a good first degree in a relevant scientific discipline, or equivalent teamed with regulatory experience with worldwide registrations, ideally within a senior role but not essential.
- You must be able to connect and work effectively with various teams and be cross culturally aware.
Together with:
- Experience with the Medical Devices Directive.
- Experience of drug-device and/or pharmaceuticals registrations.
- Ability to demonstrate regulatory input into NPD projects throughout product developments.
- Ability to demonstrate regulatory activities undertaken have been satisfactorily completed within agreed timescales.
If you believe you have the correct experience then please send me your CV and I will be in touch shortly.