Regulatory Affairs Manager

Get AI-powered advice on this job and more exclusive features. Sign in to access AI-powered advices Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google 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 Referrals increase your chances of interviewing at CornerStone Professional Placement by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Manager” roles. Continue with Google Continue with Google Continue with Google Continue with Google Compliance Manager, Regulatory Change Management Frisco, TX $105,600 - $198,000 2 weeks ago Food Safety and Regulatory Affairs Manager Chief Compliance Officer, Integrity Life Chief Compliance Officer, Integrity Life Manager, Hospital Regulatory & Accreditation (Remote based in US) Regulatory Compliance Manager - Food Manufacturing Dallas, TX $75,000.00 - $100,000.00 2 months ago Sr Manager Liquidity Regulatory Reporting and Infrastructure We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr