- Opportunity to be a part of a global med-tech company
- Excellent career progression opportunities
About Our Client
My client is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.
* Works with R&D to lead RA activities (as RA lead) on New Product Development projects to support the product development and CE marking from concept to commercialization
* Supports as RA lead on sustaining engineering projects for changes to released products
* Propose workable solutions for resolution of complex regulatory challenges, hands-on approach in driving projects to completion
* Maintain high level of quality and compliance (to MDR/ MDD/ company quality systems) in technical document preparation and review & approval of various product/ project specific documentation.
* Participate to the review of process/product changes, labeling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to international requirements
* Active inputs into development and review of quality system procedures & work instructions, CERs/ PSURs and input into risk mgmt.
* Development of regulatory strategies for product release and product change assessments
* Works with internal processes and cross functional teams to assess changes in standards/ regulations and help determine their impact to Business
The Successful Applicant
Demonstrated compliance experience with Class IIa/IIb - MDD/MDR medical devices, including (P)EMS - (Programmable) Electrical Medical Systems
* Sound knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking
* Experience working with International Standards like IEC/EN 60601-1 (safety)/ 60601-1-2 (EMC)/ 62304(software)/ 62366(usability), ISO 14971 (Risk Management) and ISO 13485 (QMS)Good working knowledge of Design Control, Software Life Cycle, Risk Mgmt, V&V processes
* Prior working experience on MDR preferred
* Minimum of a Bachelor's degree in scientific or engineering discipline and 5+ years of regulatory Affairs experience
* You should be an enthusiastic teammate, agile in execution with sense of ownership, in a complex and fast evolving environment.
What's on Offer
Competitive salary and benefits package