- 193809 - Regulatory Affairs Specialist
- CA-Central California
- Up to $55.00 DOE
- 6 mos
- Chipton-Ross is seeking a Regulatory Affairs Specialist for an opening in Fremont, CA.
The Regulatory Affairs Specialist will join existing team and provide support for International Registration of IVD products.
Initiation, collection, and coordination of information of regulatory documents for various purposes. Preparation and maintenance of product technical files for CE marking. Experience of EU IVDR or MDR a plus. Organization and preparation of documents for international submissions, including drafting reports, and preparing documentation for submissions. Coordination with international counterparts to obtain product approvals and renewals. Maintaining logs and trackers. Organize, update, and maintain regulatory documentation in accordance with department and company procedures.
Accredited High School Diploma/GED
Preference to local candidate who can work on site. Will accept remote if candidate is exceptional .
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x254 or (800) 927-9318 x254
To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.