Quality and Regulatory Affairs Associate
Dandy
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $75,250 - $86,000 per year
About the role
- Support registrations, submissions, and lifecycle maintenance activities required to commercialize and maintain products in Canada, the UK, and Europe.
- Compile, format, and maintain technical documentation and submission-ready records in collaboration with cross-functional teams.
- Monitor regulatory changes and guidance updates; summarize impacts and propose updates to internal processes, labeling, or documentation.
- Coordinate information requests and document retrieval for external reviewers.
- Help maintain and improve QMS processes and records to support ISO 13485 certification and ongoing compliance.
- Support internal and external audits by preparing objective evidence, retrieving records, and assisting with responses to audit observations.
- Create, format, route, and maintain controlled documents in the eQMS, including version control, periodic review, and archival of obsolete documents.
- Receive, log, review, and route product complaints for investigation; ensure timely, complete, and compliant documentation and closure.
- Support analysis and trending of complaints and post-market data; communicate signals and feed learnings into CAPA, risk management, and continuous improvement activities.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.
- 2–3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device (or other regulated) industry.
- Working knowledge of ISO 13485 and familiarity with MDSAP expectations.
- Exposure to EU MDR, UK (MHRA/UKCA), and/or Health Canada requirements is a plus.
- Experience with supporting technical documentation or submissions to a regulatory body.
- Strong technical writing, organization, attention to detail, and the ability to manage multiple priorities across teams.
Benefits
- Competitive salary and comprehensive benefits including healthcare, dental, mental health support, and retirement savings options.
- Local benefits packages typically include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
technical writingquality assuranceregulatory affairsISO 13485MDSAPEU MDRUKCAHealth Canada requirementsdocument controlCAPA
Soft Skills
organizationattention to detailability to manage multiple prioritiescollaborationcommunication