Regulatory Affairs Specialist Job at Jacobs Management Group, Inc., Norristown, PA

N0h6ZGp3dGVqS0x0enhxL1RhN043UlV2MGc9PQ==
  • Jacobs Management Group, Inc.
  • Norristown, PA

Job Description

Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, you’ll play a critical part in bringing transformative orthopedic technologies to market, helping surgeons deliver better outcomes, faster recovery times, and higher quality of life for those with musculoskeletal conditions.

Why You Should Apply

  • Join a company that thrives on innovation and real-world patient impact
  • Collaborate with cross-functional experts in a fast-paced, clinical product environment
  • Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices
  • Enjoy a culture that blends urgency, teamwork, and a passion for clinical results

What You’ll Be Doing

  • Drafting and submitting 510(k), IDE, and PMA regulatory submissions
  • Partnering with Product Development teams to align on regulatory strategy
  • Reviewing clinical data and collaborating with internal teams to support submissions
  • Maintaining PMA records, preparing supplements and annual reports
  • Training team members and contributing to SOP development and regulatory compliance

About You

  • Be able to do the job as described
  • Bachelor’s in health/science-related field; Engineering degree is a plus
  • 2-5 years’ experience in Regulatory Affairs in the medical device industry
  • Knowledge of orthopedic medical devices is highly preferred
  • Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)
  • Strong documentation, review, and cross-functional communication skills

Job Tags

Worldwide,

Similar Jobs

CyberCoders

Heavy Equipment Mechanic Job at CyberCoders

 ...offshore rigs. Key Responsibilities Conduct regular maintenance and inspections of rig equipment and systems Troubleshoot mechanical and electrical issues to ensure operational efficiency Operate and maintain Blow Out Preventer (BOP) systems Implement... 

Onward Search

Part-time School Psychologist [78983] Job at Onward Search

 ...School Psychologist Part-Time Location: Westwood, MA Hiring Company: Onward Search Schedule: Tuesday, Wednesday, Thursday | 9:00 AM 2:00 PM Rate: Based on experience About the Role: Onward Search is seeking a Massachusetts DESE-licensed School... 

TPI Global Solutions

Human Resources - Curriculum Design & Development Job at TPI Global Solutions

 ...environment. Preferred Qualifications ~35 years experience using multimedia features (audio, graphics, digital photography, animation, gamification). ~ Experience developing solutions for mobile learning, microlearning, and blended learning environments. ~... 

Pyramid Consulting, Inc

Senior Analyst - Document Automation & Integration Job at Pyramid Consulting, Inc

Immediate need for a talented Senior Analyst Document Automation & Integration. This is a 12+ months contract opportunity with long-term potential and is located in Titusville, NJ (Remote). Please review the job description below and contact me ASAP if you are ...

Keadjian

Account Manager | Corporate Communications Job at Keadjian

 ...Account Manager | San Francisco Bay Area | Hybrid Work Public Affairs | Corporate Communications Energy | Land Use | Infrastructure Keadjian Associates, a leading strategic communications and management consulting firm in the San Francisco Bay Area, is seeking...