Job Title: Senior Regulatory Affairs Specialist
Location: San Diego, CA
Experience: Must have experience composing submissions for IVD devices
Position Overview:
The Sr. Regulatory Affairs Specialist will coordinate the collection of technical information and prepare regulatory submissions for in vitro diagnostic (IVD) and medical device licenses for various governmental agencies. Additionally, they will coordinate clinical study trials, including offsite locations when necessary.
Key Responsibilities:
- Coordinate submission and review of documents for inclusion in Design History Files.
- Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings.
- Prepare post-market product surveillance reports.
- Prepare EU/UK vigilance reports as needed.
- Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions.
- Assist in the registration and application process for Class II & III Medical Device Licenses in Health Canada.
- Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK MDR2002 guidance documents.
- Review labeling, package inserts, advertising materials, and company website content to ensure compliance with FDA and CE regulatory requirements.
- Maintain and update regulatory documentation and track submissions.
- Ensure compliance with Essential Requirements Checklists and applicable standards as revisions are introduced.
- Provide technical documentation to Competent Authorities and Notified Bodies.
- Assist OEM customers in obtaining CE marks for their products.
Education & Experience:
- Bachelor’s degree in a related field or equivalent experience.
- Minimum of 6-7 years of experience, with at least 3 years of experience in preparing and submitting 510(k) or CE technical files for IVD devices.
Required Skills & Abilities:
- Strong working knowledge of medical device regulations and terminology.
- Excellent written and oral communication skills, including technical writing and editing.
- Ability to produce clear, concise technical documentation.
- Skilled in analyzing and summarizing data.
- Proficient with Microsoft Office.
- Ability to manage and prioritize multiple projects in a fast-paced environment.
- High attention to detail and accuracy in following written and verbal directions.
- Ability to work collaboratively in a team setting.
- Knowledge of QSRs, ISO 13485, IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.
$115k-$127k
