Regulatory Affairs Manager

Regulatory Affairs Manager

City: Frisco

State: Texas

Zip: 75034

CornerStone Professional Placement is seeking a Regulatory Affairs Manager for a medical device manufacturing client in the Frisco, TX area. As the Regulatory Affairs Manager, you will be responsible for overseeing regulatory processes and ensuring submissions comply with U.S. and European medical device standards. You will thrive in this role if you have leadership experience, strong regulatory knowledge including 510(k) and CE marking submissions, and a background in biomedical or science disciplines. This is an exciting opportunity to lead in a high-impact, direct hire role with a company committed to overhauling and improving its Regulatory Affairs operations.

What You’ll Actually Do as the Regulatory Affairs Manager:

• Prepare and manage regulatory submissions in compliance with U.S. and EU medical device regulations
• Maintain and update technical files for CE marking and 510(k) approvals
• Lead and guide a team of regulatory professionals
• Monitor evolving compliance standards and ensure internal policies meet industry requirements
• Collaborate with cross-functional teams to support new product development and international market access

What You’ll Need to Succeed as the Regulatory Affairs Manager:

• Bachelor’s degree in biomedical engineering or a related science field
• At least 3 years of experience in medical device regulatory affairs
• Proven leadership or team management experience
• Experience with CE marking, 510(k) submissions, and technical file maintenance
• Strong organizational, analytical, and communication skills

It’s a bonus if you’ve used:

• EU MDD standards in a medical device regulatory setting
• Documented success in process improvement within a regulatory team

Why This Role Fits Your Life:

Employment type: Direct Hire

Schedule: Monday-Friday, 7:00 AM-4:00 PM or 8:00 AM-5:00 PM

Salary/Pay: $90,000-$130,000/year (commensurate with experience)

Location: 100% On-site

Benefits: Medical, Dental, Vision, Life, AD&D, Disability, HSA, FSA, 401(k) with matching, Employee Assistance Program, Tuition Reimbursement, Paid Holidays, Paid Vacation, and more!