Senior Regulatory Affairs Associate / Regulatory Specialist - Medical Devices Job at Jacobs Management Group, Carlsbad, CA

b0s5TFR2S1h3OTFGc3UvajQ3OEZJc29STXc9PQ==
  • Jacobs Management Group
  • 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

 

How To Apply

We’d love to see your resume, but we don’t need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell me why you’re interested. Or, if you do have a resume ready, apply here.

Job Tags

Permanent employment, Full time,

Similar Jobs

Deloitte

Cisco Network Engineer- CCIE/CCNP preferred Job at Deloitte

 ...planning and engineering (hardware and software) and optimization.+ 3+ years of recent experience performing routing & switching within Cisco environments and a strong knowledge of protocols such as: BGP, OSPF, IPv4/IPv6+ 1+ years with previous people/process management... 

Amazon Kindle Writers Wanted

Work from Home AI Content Writer - Publish Mini eBooks with Full Training Provided Job at Amazon Kindle Writers Wanted

 ...Work from Home AI Content Writer Publish Mini eBooks with Full Training Provided About the Role A digital publishing network is hiring...  ...nonfiction guides on beginner-friendly topics, format them to Amazon standards, and manage the upload process through a step-by-... 

Focused HR Solutions

8-11 QA Tester Job at Focused HR Solutions

 ...Local to Raleigh, NC only. This job is remote you may be required to come on site. Our client has an opening for a QA Tester 735026 This position is up to 12 months, with the option of an extension, and the client is in Raleigh, NC Please send rate and resume... 

Epsilon

Principal, HR Business Partner (Director) Job at Epsilon

Overview How Youll Make an Impact As a Director, Human Resources at Epsilon, you will be a strategic partner and trusted advisor to senior executives within our Sales and Go-to-Market (GTM) organization. In this high-impact role, you will influence and guide...

The Shelly Company

Underground Mining Foreman Job at The Shelly Company

 ...the industry for innovation, quality and for our commitment to safety. Position Overview Oversee and direct operations of an underground aggregate mining crew, including personnel, equipment, trucking, and materials. Key Responsibilities (Essential Duties and...