Arterys is seeking an experienced Sr. Regulatory Affairs Analyst to lead the medical device software development regulatory activities. The primary function of this position is to coordinate, prepare and file regulatory submissions in the US and OUS markets, interpret regulatory rules and create awareness within the organization regarding the US and OUS regulations and product specific standards. The ideal candidate will have experience with software-based medical devices and enjoys the fast-paced “up-for-anything” type of environment that is our every day at Arterys. This position is based in Arterys’s San Francisco headquarters.
We are a venture-backed startup developing bleeding edge solutions in the space where artificial intelligence meets Medical Imaging and Healthcare. As the first mover in this space, Arterys has a unique opportunity to establish a strong foothold in the market with our high performance intelligent diagnostic decision support solution.
- Drive regulatory strategy for US and OUS markets: develop global regulatory strategies and drive the international product registration activities (with focus on EU, Canada, Australia, Japan, China and South Korea).
- Prepare, coordinate, and file global regulatory submissions/approvals.
- Support the product development team in the implementation of regulatory requirements, including review of design input, risk management, and test documentation.
- Prepare and submit regulatory filings including, Traditional and Special 510(k) applications, Letters to File, Technical Files, etc.
- Perform regulatory assessment of product changes.
- Perform MDR and MDV complaint reporting assessments.
- Proactively interpret regulatory guidelines and regulations, anticipate concerns, educate, and integrate requirements into product development programs.
- Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
- Ensure regulatory requirements for establishment registrations, device listings, and registration licensing is maintained.
- Support internal and external audits.
- Bachelor’s degree
- 2-5 years of Regulatory experience with Class II medical devices.
- In depth knowledge ISO13485, 21 CFR 820, IEC 62304 and ISO 14971.
- Experience in submissions and technical documentation for medical device company.
- Experience with new product development projects for software product.
- Ability to review and provide critical feedback on design documentation.
- Excellent command of the English language; ability to draft and revise QMS documents with consistency of format and language; Mac and Google apps proficient.
- Experience with medical device as a software and agile development is a plus.
- Strong interest in working for a startup and the mindset required to be successful.
Arterys is an Equal Opportunity Employer committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.
If you are qualified and interested in the above position, please email your resume with cover
letter to email@example.com with Sr. Regulatory Affairs Analyst in the subject line.