Senior Regulatory Affairs Associate Job at Jacobs Management Group, Inc., Carlsbad, CA

QWtNQVlTZHlxSnYrc3Z6U2FKYXIxTU5Z
  • Jacobs Management Group, Inc.
  • Carlsbad, CA

Job Description

Step into a role where your regulatory expertise helps bring life-enhancing medical technologies to market. My client is seeking a driven Senior Regulatory Affairs Associate to support U.S. and global submissions for innovative devices developed in Carlsbad, CA. Your work will directly impact patient access to groundbreaking neuromodulation therapies.

Why You Should Apply

  • Help bring cutting-edge neuromodulation devices to market
  • High-impact role supporting global regulatory submissions
  • Be the regulatory expert on a collaborative, cross-functional team

What You’ll Be Doing

  • Developing and executing regulatory strategies for U.S. and international submissions
  • Preparing and submitting FDA 510(k)s, PMAs, technical files, and change orders
  • Serving as a subject matter expert on regulatory guidelines and inspections
  • Supporting cross-functional teams on product development and changes
  • Advising on regulatory impacts of decisions and submissions globally

About You

  • Be able to do the job as described
  • 8+ years of experience in medical device regulatory affairs
  • Knowledge of neuromodulation products or similarly complex devices is a plus
  • Familiarity with global regulatory frameworks beyond the FDA
  • Degree in engineering, science, or a related technical field

Job Tags

Similar Jobs

Lion Freight Systems Inc

CDL A Dry Van Truck Driver - OTR Job at Lion Freight Systems Inc

 ...layovers, and extra stops Weekly direct deposit every Friday ( Monday-to-Monday pay schedule , 1099 position ) Late-model trucks (20202024 Volvo, Freightliner, Kenworth, Peterbilt ) fridge, microwave, and inverter included 48ft dry van trailers no-... 

Bull Integrations Group Inc.

Tooling Engineer - Aerospace Manufacturing Job at Bull Integrations Group Inc.

 ...Tooling Engineer - Aerospace Manufacturing Columbus, MS 39701, USA Job Details Description Key Responsibilities: Design...  ...production flow. Ensure strict compliance with all relevant industry standards, regulations, and safety protocols. Qualifications... 

LHH

Special Assets Manager Job at LHH

 ...Were seeking an experienced Special Assets Manager to oversee a portfolio of distressed commercial real estate loans. This is a strategic, hands-on role focused on loan workouts, restructures, and risk mitigation. The ideal candidate will bring a strong background in... 

Inkling

Art Director Job at Inkling

 ...Inkling is a creative agency renowned for crafting immersive experiences that bridge the digital and physical worlds. We're looking for an Art Director to join our team and play a pivotal role in shaping brand narratives, developing compelling art direction, and championing... 

Cross Border Talents

Join Us as an Italian-speaking Reservations Agent in Malta Job at Cross Border Talents

 ...Join Us as an Italian-speaking Reservations Agent! (Local candidates only) Start Date: August 26 Location: Onsite Role Overview: Assist customers over the phone, converting inquiries into sales while providing exceptional support and handling customer...