Regulatory Affairs Associate - Medical Devices
Position: Regulatory Affairs Associate
A fantastic opportunity has become available for a talented Regulatory person to step into a fast paced company and join them during a time of rapid growth. This innovative and dynamic company value internal growth and promotion and will be looking for someone to work independently, take responsibility and quickly move into a managerial position.
They pride ourselves on doing things differently, breaking the mould and not being your typical medical device company. They require someone who is ambitious and wants to progress their career within the medical device sector.
Compile product information for the preparation of technical files and regulatory dossiers to support product licence applications and product license maintenance for worldwide Regulatory Authorities.
Advise Spectrum Medical staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other regulatory requirements as identified.
Liaise with regulatory agencies and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
Participate in a programme of continuous training and assessment to maintain and develop professional skills.
-BSc degree in life sciences.
-3 or more years Regulatory Affairs experience in a medical device, electro-mechanical or software company.
-Awareness of global regulatory and medical device environments (Class IIb Medical Devices preferred).
-Excellent communication skills, written and oral.
-Excellent organisation and time management skills.
-Excellent computer skills.
This is a fantastic opportunity to really progress your career within our company. Spectrum Medical are expected to double in size over the next 18 months and this position will give you an opportunity to move into management and grow a regulatory team around you. They are offering a competitive package and training for those with less experience.
If this is something that you would like further details on, please contact Jack Lacy on +44 (0) 121 616 3467 for a confidential discussion, or alternatively email email@example.com.
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