Director of Regulatory Affairs (Fremont) Job at Connect Life Science, Fremont, CA

c0Y5OUFxaUtZZjIyZ3QyV29IWW5lTUM0ZlE9PQ==
  • Connect Life Science
  • Fremont, CA

Job Description

Senior Director of Regulatory Affairs

Hybrid working - some travel to Bay Area

Medical Devices Class III

Competitive compensation + strong benefits

A growing medical device company developing Class III Medical Devices are seeking a Senior Director of Regulatory Affairs to lead strategy and execution across the US.

This is a hands on + leadership role; ideal for someone with deep regulatory knowledge in the US and a passion for mentorship, cross-functional collaboration, and innovation in a fast-paced, mission-driven environment.

What Youll Be Doing:

  • Lead a talented regulatory team in developing and executing submission strategies (PMA, IDE etc.) for class III medical devices
  • Own regulatory planning and agency interactions (FDA, Notified Bodies, international authorities)
  • Collaborate across R&D, clinical, quality, and marketing to ensure global compliance
  • Support audits, inspections, and implement proactive risk mitigation strategies
  • Manage regulatory compliance function and product-focussed RA team
  • Influence the broader business by aligning regulatory activities with commercial priorities

Who Were Looking For:

  • 10+ years in regulatory affairs, ideally with some Class III implantable devices
  • Strong working knowledge of U.S. FDA and regulatory submissions
  • Experience with PMA/IDE submissions
  • Proven team leader and strategic thinker
  • Excellent communication skills, comfortable engaging with executives and regulators alike

This is a fantastic opportunity to be a key regulatory leader within a growing organization that's genuinely improving lives.

Apply today for a call back to discuss - this position will move to interview and offer in mid-October!

Job Tags

Part time,

Similar Jobs

Hanna Interpreting Services LLC

Spanish Interpreter Job at Hanna Interpreting Services LLC

Overview Hiring Freelance Spanish Interpreters throughout Nevada State. Hanna Interpreting Services LLC is a language service provider that connects bilingual and multilingual individuals with opportunities to serve as a freelance interpreter or translator. Hanna is seeking... 

Sanford Health

RN Inpatient - Med/Surg/OB - PRN Job at Sanford Health

 ...adaptable, great communicators, detail-oriented and have excellent time management skills. Because innovation impacts everything we do,...  ...offers an attractive benefits package for qualifying full-time and part-time employees. Depending on eligibility, a variety of benefits... 

Hand & Stone - Wichita

Licensed Esthetician Job at Hand & Stone - Wichita

 ...environment with lots of perks? Then look no further because Hand and Stone wants to talk to you!!We are in search of a Licensed Esthetician looking for a long term role in a stable and positive environment. Your expertise in skin care and product knowledge will make... 

Retro Fitness

Group Fitness Instructor Job at Retro Fitness

 ...Responsibilities:~Teaching scheduled classes, beginning & ending on time.~Providing adequate warm-up, class content, stretching & cool...  ...Compensation: $27.00 per hour With more than 120 gyms open or under development across the US, Retro Fitness offers multiple... 

Learning Care Group

Child Care Director Job at Learning Care Group

 ...intellectual growth of the children under his/her care and works with the Schools staff to create an environment of learning while keeping parents informed of the progress of their child. Job Responsibilities: Make a difference every day! Manages School staff by...