Medical Device Regulatory Affairs Specialist, Pre-Market
Medical Device Regulatory Affairs Specialist, Pre-Market
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$ 80000 - 90000
1 Vacancy
Job Description
Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role youll 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 Youll 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
- Bachelors 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
How To Apply
Wed love to see your resume but we dont need it to have a conversation. Send an email to and tell me why youre interested. Or if you do have a resume ready apply here.
Required Experience:
Unclear Seniority
Employment Type
Full Time
