Regulatory Affairs Specialist
2 weeks ago
Regulatory Affairs Specialist
The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed.
Essential Duties and Responsibilities
- Coordinates submission and review of documents for inclusion in Design History files.
- Drafts, edits and compiles technical documentation and design dossier in support of CE mark/UKCA mark regulatory filings.
- Responsible for the preparation of post-market product surveillance reports
- Responsible for the preparation of EU/UK vigilance reports as needed.
- Prepare regulatory submissions for FDA A2F.
- Assist on the Registration/Application of Class II & III Medical Devices Licenses in Health Canada.
- Research FDA, CMDR, MDR, IVDR and UK MDR2002 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.
- Maintain Essential Requirements Checklists- ensuring that applicable standards are utilized and updated as revisions are introduced.
- Provide Technical Documentation to Competent Authorities and Notified Bodies.
- Assist OEM customer in obtaining the CE mark on their products.
Education and/or Experience
- Bachelors in related discipline or equivalency;
- Minimum 6-7 years IVD industry experience with a minimum 3 years’ experience in preparation and submission of 510k or CE technical files for IVD devices.
Required Knowledge, Skills and Abilities
· 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;
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