This is an exciting role that is working on behalf of a medium-sized medical device manufacturer specializing in Class II A Non-Sterile devices and is part of a larger umbrella company that has a portfolio of small to large device organizations.
Responsibilities:
* Carry out the departmental regulatory strategy as defined by the hiring manager.
* Support the transition from MDD to MDR
* Handle any incoming customer complaints, working closely with customer and marketing teams.
* Maintain PIC Records
Requirements:
* Around 5 years in a Regulatory Affairs role in a Medical Device company
* Certified in ISO13485
* Certified in MDR
* Experience with complaint handling
* English Langauge skills
* Experience with MDD -MDR transitions.
* Good understanding of the whole product lifecycle
* Experience with UDI’s is great to have
Other:
* This role is an on-site role, after 6 months the client can offer more flexibility, ideally they would want the incumbent to become situated before any flexibility can be provided. 1-2 days provisionally.
* 90% of the site speak and work in English, this is an English-speaking role
* No team management is involved.