Regulatory Affairs Specialist
24 hours ago
Cypress HCM seeks a skilled Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. This role involves coordinating clinical study trials, including offsite locations as needed.
Key Responsibilities- Submission Coordination: Coordinate the submission and review of documents for inclusion in Design History files.
- Technical Documentation: Draft, edit, and compile technical documentation and design dossiers in support of CE mark/UKCA mark regulatory filings.
- Post-Market Surveillance: Prepare post-market product surveillance reports.
- Vigilance Reports: Prepare EU/UK vigilance reports as needed.
- Regulatory Submissions: Prepare regulatory submissions for FDA A2F.
- Medical Device Licenses: Assist with the registration/application of Class II & III Medical Devices Licenses in Health Canada.
- Guidance Research: Research FDA, CMDR, MDR, IVDR, and UK MDR 2002 guidance documents for regulatory requirements.
- Labeling Review: Review labeling, package inserts, ad materials, and company websites to meet FDA and CE regulatory requirements.
- Documentation Maintenance: Maintain, track, and update regulatory documentation.
- Essential Requirements Checklists: Maintain Essential Requirements Checklists, ensuring applicable standards are utilized and updated as revisions are introduced.
- Competent Authorities: Provide technical documentation to competent authorities and notified bodies.
- OEM Assistance: Assist OEM customers in obtaining CE marks on their products.
- Bachelor's Degree: Bachelor's degree in a related field or equivalency.
- Industry Experience: Minimum 6-7 years IVD industry experience, with a minimum 3 years' experience in preparing and submitting 510k or CE technical files for IVD devices.
- Regulatory Knowledge: Strong working knowledge of medical device regulations and terminologies.
- Communication Skills: Excellent written and oral communication, and technical writing and editing skills.
- Data Analysis: Ability to write clear, understandable technical documentation and analyze/summarize data.
- Project Management: Ability to manage and prioritize multiple projects.
- Aaccuracy: Ability to follow written and verbal direction with high accuracy.
- Teamwork: Ability to work in a team setting.
- Regulatory Frameworks: Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.
The estimated salary range for this position is $90,000-$120,000 per year, depending on qualifications and experience.
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