Senior Regulatory Affairs Specialist

Regulatory Affairs Specialist & Quality Assurance Specialists - Apply Here

We are working with a Medical Device company based in Cincinnati, OH, looking for RA/QA Specialists to come a join the team. This is a small company, so we're looking for people who can wear multiple hats, work well independently and within a team and want to progress in their careers.

You will be:

• Maintenance of Quality Management Systems to ISO 13485:2016
• Involved in Post Market Surveillance activities
• Supporting pre-market activities -US FDA 510(k), MDR
• Dealing with Customer Complaints
• Maintain, update and track regulatory requests - provide periodic status updates to open and closed requests
• Maintain regulatory files for product compliance

Experience/Qualifications:

• 4+ years of Medical Device experience
• Knowledgeable of Medical Devices Regulations and Guidances
• Maintained a QMS to ISO 13485:2015
• Previous submissions experience (510(k), EUMDR etc.)
• Bachelors in a related Scientific discipline is preferred

thomas.hatfield@acepartners.co.uk

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