Regulatory Affairs Specialist is responsible for obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual will be capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory requirements to future products to ensure compliance of the product to pre-market regulatory clearances.
This position reports to the
Director, Regulatory Affairs and is part of the Regulatory Affairs team located in
Irvine, CA and will be an
on-site role. In this role, you will have the opportunity to: - Support the regulatory team managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, technical files, STED Documents and related submissions.
- Coordinate with regional regulatory team members on product changes and regulatory notification / approval requirements.
- Assist in communications with regional regulatory representatives to assist in filings and responses to inquiries from health authorities and notified bodies worldwide.
The essential requirements of the job include:- 2+ years of work experience in a medical device Class II/ III environment.
- Bachelor's degree is required, preferably in Engineering or Life Sciences.
- Excellent documentation skills including record maintenance/ tracking and understand document traceability.
It would be a plus if you also possess previous experience in: - Regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.
- FDA/GMP requirements for medical device.
- Quality Systems per ISO 13485.
- Graduate Degree
Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $80,000 - $100,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Bonus / Incentive Pay 10% of annual base salary
This job is also eligible for bonus / incentive pay. This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions.
This job is also eligible for a comprehensive package of benefits. Details regarding these benefits will be provided separately.
