Our client is a medical device company, and they are looking for a regulatory affairs specialist who understands the technical documentation processes for EU regulatory and quality standards for 7 new products. They follow ISO 13485 regulations and have 2 ISO certifications, and they are currently working to get MDSAP. They need someone who can come in a confidently take 17 technical files which are already completed, pull additional content, make changes if needed, and compile the files to send overseas so they can properly store the documents in the EU and confirm each products compliance.
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2+ years of professional IVDD/IVDR/MDD or MDR regulation knowledge and experience.
Experience documenting the regulatory/quality/compliance processes for EU standards.
Experience with technical file creation and upkeep.
Post market surveillance reporting experience.
Regulatory agency reporting experience.
ISO 13485 and MDSAP knowledge and experience.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.