Regulatory Affairs Manager

Real Staffing; Derry (NH); On-site; USD 110,000 - 160,000; Full time

Job summary

Real Staffing seeks an experienced Regulatory Affairs Manager to join a growing medical device organization focused on innovative healthcare technologies. You will develop regulatory strategies, manage submissions, and ensure global compliance to bring products to market.

The role requires 5+ years in regulatory affairs within medical devices or IVD, hands-on FDA 510(k) and CE Marking experience, and strong knowledge of ISO 13485, MDR/IVDR, and related standards.

Qualifications

• Bachelor's degree in Biological Sciences, Medical Technology, or related discipline.
• 5+ years of regulatory affairs experience within the medical device and/or IVD industry.
• Hands-on experience preparing or supporting FDA 510(k) submissions and technical files.
• Strong understanding of FDA Medical Device Regulations (QMSR), ISO 13485, MDR/IVDR, and CE Marking processes.
• Experience interacting with regulatory agencies and notified bodies.

Responsibilities

• Lead the preparation, submission, and approval of Class II Medical Device and IVD regulatory filings.
• Develop and manage country-specific regulatory submissions for global markets.
• Prepare, maintain, and update technical documentation and technical files.
• Support CE Marking activities and international product registrations.
• Review and approve product labeling, promotional materials, and advertising to ensure regulatory compliance.
• Oversee product complaint handling processes in accordance with FDA and international requirements.
• Assist with adverse event reporting activities, including MDR documentation and agency communications.
• Participate in risk management activities, hazard analyses, and design reviews.
• Evaluate and document regulatory impacts of product changes, including 510(k) non-filing justifications.
• Serve as a regulatory subject matter expert for leadership and cross-functional teams.
• Monitor changing regulatory requirements and industry standards globally.
• Collaborate with regulatory agencies, notified bodies, and international standards organizations.

Skills

Regulatory strategy

FDA submissions

CE Marking

ISO 13485

MDR/IVDR

Cross-functional collaboration

Project management

Regulatory affairs

Education

Bachelor's degree in Biological Sciences / Medical Technology or related

Job description

We are seeking an experienced Regulatory Affairs Manager to join a growing medical device organization focused on innovative healthcare technologies. This individual will play a critical role in developing and executing regulatory strategies, ensuring compliance with global regulations, and supporting product development through successful regulatory submissions and approvals.

What You'll Do

• Lead the preparation, submission, and approval of Class II Medical Device and In Vitro Diagnostic (IVD) regulatory filings.
• Develop and manage country-specific regulatory submissions for global markets.
• Prepare, maintain, and update technical documentation and technical files.
• Support CE Marking activities and international product registrations.
• Review and approve product labeling, promotional materials, and advertising to ensure regulatory compliance.
• Oversee product complaint handling processes in accordance with FDA and international requirements.
• Assist with adverse event reporting activities, including MDR documentation and agency communications.
• Participate in risk management activities, hazard analyses, and design reviews.
• Evaluate and document regulatory impacts of product changes, including 510(k) non-filing justifications.
• Serve as a regulatory subject matter expert for leadership and cross-functional teams.
• Monitor changing regulatory requirements and industry standards globally.
• Collaborate with regulatory agencies, notified bodies, and international standards organizations.

Qualifications

Required

• Bachelor's degree in Biological Sciences, Medical Technology, or a related discipline.
• 5+ years of regulatory affairs experience within the medical device and/or IVD industry.
• Hands-on experience preparing or supporting FDA 510(k) submissions and technical files.
• Strong understanding of:
  • FDA Medical Device Regulations (QMSR)
  • ISO 13485
  • MDD, MDR, IVDD, and IVDR requirements
  • CE Marking processes
• Experience interacting with regulatory agencies and notified bodies.
• Strong written, verbal, and stakeholder communication skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.

Preferred

• Experience with Canadian Medical Device regulations.
• Knowledge of GMP, QMSR, ISO 13485, MDR/IVDR implementation.
• Previous leadership or team management experience.

What We're Looking For

The ideal candidate is a proactive regulatory professional who combines technical expertise with strong business acumen. You thrive in cross-functional environments, build strong relationships across teams, and enjoy navigating complex regulatory challenges to bring innovative healthcare products to market.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.