Regulatory Affairs Associate

Medical Device Developer in the north west of England is searching for a Regulatory Affairs Associate to assist them with an Exciting new project.

Key Accountabilities:
* To compile and submit regulatory submissions for approval to regulatory authorities worldwide.
* To create and maintain Technical Files, Design Dossiers, PMA and 510(k) files
* To support and advise other functions within the business for information requests, drug tariff applications, review of artwork and literature review.
* Support customer market registration activity, within the terms of existing contractual obligations.
* Responsible for regulatory review and approval of key compliance records (e.g. Labelling and instructions for use) for all sites.
* Support Technical File and Design Dossier audits/reviews by Notified Bodies.
* Participate in company quality system audits.

The ideal candidate will have:
* Degree or equivalent qualification in a scientific discipline
* Previous relevant experience of working in the medical device arena preferably in a regulatory role or alternatively in a QA role.
* Knowledge of GMP and GLP (MDD 93/42/EEC, USA FDA QSR, CMDCAS and ISO 13485)
* Previous experience in preparation of and obtaining 510(k) clearance desirable
* Previous experience in preparation and obtaining Design Dossier approvals desirable
* Experience in key market clearance requirements such as FDA, Canadian registrations, listings and licences; CE certification and Design Examination Certification.
* Able to demonstrate excellent planning and organisational skills
* Able to deliver to critical deadlines
* Excellent communication skills both written and verbally with employees, customers and suppliers.
* Competent IT skills
* Must be willing to travel to other Company locations on a regular basis (approx once per month)

If you think you have the relevant experience, or you know someone who has, then feel free to contact Joseph.

To find out more about Real Staffing please visit www.realstaffing.com