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Regulatory Affairs Specialist
1 month ago
At ACON Laboratories, we are committed to developing innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.
The ideal candidate will have a strong background in medical devices regulations and terminologies, with a minimum of 6-7 years of experience in the IVD industry. They will be responsible for coordinating the accumulation of technical information and preparing submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.
Key Responsibilities:
- Coordinate submission and review of documents for inclusion in Design History files.
- Draft, edit, and compile technical documentation and design dossier in support of CE mark/UKCA mark regulatory filings.
- Prepare post-market product surveillance reports and EU/UK vigilance reports as needed.
- Research FDA, CMDR, MDR, IVDR, and UK MDR 2002 guidance documents for regulatory requirements.
- Review labeling, package inserts, ad materials, and company website to meet FDA and CE regulatory requirements.
- Maintain, track, and/or update regulatory documentation.
- Provide Technical Documentation to Competent Authorities and Notified Bodies.
- Assist OEM customers in obtaining the CE mark on their products.
Requirements:
- Bachelor's degree in a related discipline or equivalency.
- Minimum 6-7 years of IVD industry experience with a minimum 3 years' experience in preparation and submission of 510k or CE technical files for IVD devices.
- Strong working knowledge of medical devices regulations and terminologies.
- Excellent written and oral communication, and technical writing and editing skills.
- Ability to write clear, understandable technical documentation.
- Ability to focus in a busy environment.
- Skilled at analyzing and summarizing data.
- Proficient with Microsoft Office.
- Ability to manage and prioritize multiple projects.
- Ability to follow written and verbal direction with a high level of accuracy.
- Ability to work in a team setting.
- Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.
We offer a competitive benefits and compensation package, as well as a supportive team environment. If you are a motivated and experienced Regulatory Affairs Specialist, we encourage you to apply for this exciting opportunity.
