About this opportunity
CornerStone Professional Placement lists this Regulatory Affairs Manager opportunity in frisco, Texas. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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CornerStone Professional Placement provided pay range
This range is provided by CornerStone Professional Placement. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$100,000.00/yr - $130,000.00/yr
Direct message the job poster from CornerStone Professional Placement
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!
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance, Management, and Legal
Industries
Medical Equipment Manufacturing and Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Disability insurance
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Worksite address
frisco, TX, 75034, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.