Regulatory Affairs Manager

CornerStone Professional Placement

Frisco (TX)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Medical, Dental, and Vision insurance

401(k) with matching

Tuition Reimbursement

Paid Holidays and Vacation

Employee Assistance Program

Job summary

A leading company in medical device manufacturing is seeking a Regulatory Affairs Manager in Frisco, TX. This role demands oversight of regulatory compliance and submissions for U.S. and European standards. The ideal candidate will possess strong leadership skills and a proven background in regulatory affairs, including experience with 510(k) and CE marking submissions. This direct hire opportunity not only offers a competitive salary but also an array of benefits.

Qualifications

3+ years of experience in medical device regulatory affairs.
Proven experience with CE marking and 510(k) submissions.
Background in biomedical or science disciplines.

Responsibilities

Oversee regulatory processes for U.S. and EU standards.
Prepare and manage regulatory submissions.
Lead a team of regulatory professionals.

Skills

Leadership

Regulatory knowledge

Organizational skills

Analytical skills

Communication skills

Education

Bachelor’s degree in biomedical engineering or related science field

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