San Francisco Bay Area, CA
Senior Regulatory Affairs Specialist (domestic & EU)
Santa Clara, CA
The Sr. Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for the company. The Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements with a focus on the United States and the EU. Under direction of responsible Regulatory Affairs Management, acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and supports new product development.
Essential Job Functions
- Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units.
- Outline submission and approval requirements in assigned geographies.
- In consultation with Regulatory Affairs Management, develop sound regulatory strategies in alignment with business priorities and update strategy based upon regulatory changes.
- Provide regulatory input and technical guidance to product development and operations teams.
- Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).
- Evaluate and maintain current regulatory policies, processes, procedures.
- Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
- In collaboration with cross-functional team members, compile, prepare, review and submit on time and high-quality regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.).
- Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals.
- Communicate application progress to internal stakeholders.
- Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
- Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
- Prepare and maintain annual licenses, registrations/listings for assigned geographies.
- Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
- Provide regulatory input for product recalls and recall communications.
- Evaluate import/export requirements.
- Identify emerging issues.
- Effectively and accurately write and edit technical documents.
- Plan and conduct meetings, create project plans and timelines, and manage projects.
- Exercise good and ethical judgment within policy and regulations.
- Perform multiple tasks concurrently with accuracy.
- Provide guidance to functional groups in the development of relevant data to complete a regulatory submission.
- Provide other country specific regulatory support.
- Bachelor’s degree in science, math, engineering, or medical fields is preferred. Post-graduate degree in a technical area, M.B.A. or law is preferred.
- Minimum 5 years of regulatory affairs experience in the medical device industry. Class III medical device experience preferred.
- Must be able to travel as needed, approximately 2-3 times a year.
- Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.
- Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and international filings (TGA, Health Canada, Shonin, CFDA, etc.).
- Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
- Clear and effective verbal and written communication skills with diverse audiences and personnel.
- Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- 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.