San Francisco Bay Area, CA
Regulatory Affairs Specialist
Santa Clara, CA
The Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements. Under the direction of the Regulatory Affairs Team, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department, including submission support and maintenance of existing product files, and ensures that deadlines are met.
Essential Job Functions
- Assist with compiling, preparing, reviewing and submitting regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)
- Assist with the preparation of OUS product registration(s) documents by working with Authorized Representatives in EU, distributors, and/or Local Responsible Person (LRP)
- Provide other country specific regulatory support
- Maintain Regulatory shipping authorization documentation for assigned geographies
- Assist with review of R&D, quality, preclinical and clinical documentation for submission filing
- Prepare and maintain annual licenses, registrations/listings, and registration renewal documentation
- Work with Regulatory management, product development, quality and operations functions to assist with interpretation and compliance of applicable standards (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
- Effectively communicates, prepares, and negotiates with internal stakeholders. Properly interprets and applies regulatory requirements.
- Evaluate import/export requirements
- Ensure personal compliance with applicable company policies and procedures
- Write and edit technical documents.
- Ability to perform multiple tasks concurrently with accuracy
- Knowledge of business functions and cross group dependencies/relationships
- Support functional groups in the development of relevant data to complete a regulatory submission
- Bachelor’s degree or equivalent experience. Bachelor’s degree in science, math, engineering, or medical fields is preferred.
- Minimum 2 years of experience in a regulatory position in a regulated healthcare industry.
- Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations
- Experience with pre- and post-market medical device submissions support such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and/or international filings (TGA, Health Canada, Shonin, CFDA, etc.).
- Exercise good and ethical judgment within policy and regulations
- Think analytically with good problem-solving skills
- Clear and effective verbal and written communication skills with diverse audiences and personnel
- Proficiency in MS Word, Excel, Adobe and Power Point
- Ability to work collaboratively in a fast-paced environment while managing multiple priorities
- Operate as a team and/or independently while demonstrating flexibility to changing requirements.
- Some medical device software engineering background or experience is preferred