Regulatory Affairs Manager - Medical Device - Home BasedSRG are currently recruiting for a RA Manager to join an SME Medical Device company who are looking for someone to work on their critical surgical product range. You will be responsible for ensuring that are products comply with the applicable regulatory requirements needed to support patients & clinicians. You'll be driving both the Regulatory and Clinical strategy, providing support to new product development and guiding operations on regulatory standards.This is a brilliant opportunity for someone to manage a diverse and expanding product portfolio from a regulatory standpoint. We are looking for someone who is hands-on in their approach, and who has previous Surgical Regulatory experience. You can be based from anywhere but you will need to travel to their dedicated surgical manufacturing sites, and HQ, on an occasional basis.What we're looking for?* Science based degree or equivalent working experience with proven record in the medical device arena, preferably in combination products such as drug delivery or surgical products.* Strong leadership in managing a team from multiple sites.* Strong project management skill, preferably in clinical study or user study* Good knowledge of European, USA, Canada, rest of the world medical Devices Regulatory requirements.* Experience in preparation of and obtaining 510k clearance/PMA approval would be essential.* Experience in preparation and obtaining Design Dossier approvals would be essential.* Experience in maintaining technical files would be essential.* Good experience in key market regulatory inspection requirements such as FDA, Canadian registrations, listings and licences; CE certification and Design Examination Certification.* Excellent communication skills both written and verbally with employees, customers and suppliers.* Competent IT skill in preparing files* Ability to work independently in managing team with minimal supervision* Jobholder must be able to demonstrate the ability to deliver to critical deadlines and manage their workload and time effectively.* Ability to do hands on work as part of the regulatory team but having to influence the broader organisationIf this could be of interest, please apply or call Laith Mustafa on 0161 868 2231 for more details.
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