Jobs

Regulatory Affairs Specialist

Greater Sacramento, CA

(Office Based - Flagship Facility - Relocation Assistance Provided)

We have an immediate job opening with a division of one of the world’s largest diagnostics & testing providers. This business offers the best of both worlds; security and funding of a $5B global parent organization, but the individuality of a ~300+ employee business that nimbly creates innovative, cutting-edge products that are diagnosing diseases better than ever. The CA site has <100 employees, low turnover, still managed by the original founders (15+ years).

The Regulatory Affairs Specialist will provide regulatory support for NPD and existing portfolios. This is a hands-on role that will oversee regulatory submissions from planning stages through execution. In this role you’ll adhere to timelines, budget, and quality, while working in a relatively autonomous, fast-paced role.  

• Effectively plan, execute and manage deliverables for complex medical products (Class II, machines & consumables)
• You must be able to effectively interpret and apply regulatory requirements for launch in the US and Internationally
• Perform review of promotional material for regulatory compliance according to country specific requirements.
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Desired Qualifications:

• Bachelor of Science required
• Min 2-15+ years of Regulatory Affairs experience (510k); with experience in a medical device, medical instrument, or biotech industry (required)
• Experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers.
• Knowledge of 21 CFR Part 820, ISO 13485, ISO 14971.
• Strong leadership, interpersonal, communication and organizational skills required.
• Must possess a high level of critical and strategic thinking skills and be a detail-oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities.
• Organized with the ability to adapt to changing priorities