Regulatory Affairs Specialist

Jacobs Management Group, Inc.; Norristown (Montgomery County); On-site; USD 62,000 - 111,000; Full time

Job summary

Join a mission-driven team as a Regulatory Specialist, focused on enhancing patient lives through innovative orthopedic technologies. You will draft and submit regulatory submissions, collaborate with cross-functional teams, and maintain essential compliance documentation. This position combines urgency and teamwork, offering a dynamic environment to contribute to medical device advancements.

Benefits

Medical insurance

Vision insurance

401(k)

Tuition assistance

Disability insurance

Paid maternity leave

Qualifications

• 2-5 years’ experience in Regulatory Affairs in the medical device industry.
• Knowledge of orthopedic medical devices preferred.
• Familiar with FDA regulatory pathways and submission types.

Responsibilities

• Draft and submit 510(k), IDE, and PMA regulatory submissions.
• Align with Product Development teams on regulatory strategies.
• Train team members on regulatory compliance.

Skills

Documentation

Communication

Regulatory knowledge

Teamwork

Education

Bachelor’s in health/science-related field

Engineering degree

Job description

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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

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Tuition assistance

Disability insurance

Paid maternity leave

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