Senior Regulatory Affairs Specialist

Jobtailor; Massachusetts; On-site; USD 120,000 - 155,000; Full time

Job summary

Jobtailor is seeking an experienced Regulatory Affairs professional to develop and execute global regulatory strategies for medical devices, including software-based solutions. You will lead submissions and agency interactions across FDA, EU MDR, NMPA, PMDA, and TGA.

Collaborate with cross-functional teams to drive compliant product development from concept to launch, mentor staff, and manage multiple regulatory projects in a fast-paced environment.

Qualifications

• Bachelor’s degree in a technical discipline; advanced degree preferred.
• 4+ years of direct Regulatory Affairs experience in medical devices.
• Advanced degree with 2+ years Regulatory Affairs experience in medical devices.
• Experience with Class I–IV software medical devices across SDLC.
• Experience in advertising and promotion reviews for medical devices (Nice to Have).
• Experience leading early regulatory interactions with authorities (Nice to Have).
• PMP certification is an asset (Nice to Have).
• Strong business acumen and planning capabilities (Nice to Have).
• Excellent interpersonal, analytical, and problem-solving skills (Nice to Have).
• Ability to manage multiple projects and use MS Office and PM tools (Nice to Have).

Responsibilities

• Develop and lead global regulatory strategies for medical devices, including software.
• Advise cross-functional teams on FDA, EU MDR, NMPA, PMDA, and TGA requirements.
• Lead pre-market submissions and agency interactions.
• Mentor regulatory colleagues and manage extended teams.
• Partner with product teams to drive compliant development and timely submissions.
• Drive risk assessments and identify efficiencies in processes.
• Represent regulatory affairs in development discussions to align on strategy.
• Engage with regulators to minimize approval delays.
• Stay current with regulatory guidance and industry trends.

Skills

Regulatory Affairs Experience

Medical Device Industry Knowledge

Global Regulatory Strategy Development

Regulatory Submissions Leadership

Cross-Functional Team Collaboration

Advertising and Promotion Review

Software Development Life Cycle

Project Management

Quantitative Analysis

Problem-Solving

Education

Bachelor’s degree in a technical discipline

Advanced degree in a scientific discipline

PMP Certification

Tools

Microsoft Office

Regulatory Submission Tools

Project Management Tools

Job description

• Develop and execute global regulatory strategies for new product development and introduction, including software-based solutions and hardware.
• Advise cross-functional teams on regional regulatory requirements, including FDA (US), EU MDR, NMPA (China), PMDA (Japan), and TGA (Australia).
• Identify and recommend optimal regulatory pathways (e.g., 510(k), PMA, IDE, CE Mark, EU Technical Files, EU Design Dossiers, China NMPA registration, Japan PMDA Shonin, Australia TGA conformity assessments).
• Lead regulatory risk assessments during product design and development, providing solutions to minimize approval delays.
• Author, review, and lead global pre-market regulatory submissions.
• Drive regulatory agency interactions, including FDA Pre-Sub meetings, Notified Body consultations, PMDA pre-consultations, and Scientific Advice processes.
• Represent the company during negotiations and reviews with FDA, Notified Bodies, NMPA, PMDA, and TGA, ensuring alignment on regulatory expectations.
• Represent the Regulatory Affairs function on product development teams, bringing the voice of the function to discussions in an effort to support creative and compliant regulatory strategies for the program.
• Partner with cross-functional team members to lead engagements with regulatory agencies for new and existing devices.
• Lead and influence the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies, marketing applications, and change management implementation.
• Engage and actively participate in compliance activities (preparation and execution) including identification of opportunities for improved efficiencies within processes.
• Act as a mentor to colleagues within the team and effectively manages an extended team.
• Stay current on regulation and guidance changes supporting advocacy work as needed to influence evolving regulatory requirements.
• Work with functional team members to ensure clear communication of project/program objectives, deliverables, and timing of key milestones.
• Partner in problem resolution in an effort to mitigate functional/program level challenges to keep objectives moving in line with program estimates.
• Work within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives driven by standards of excellence.

Requirements

• Bachelor’s degree in a technical discipline
• Minimum of 4 years of direct Regulatory Affairs experience within the medical device industry
• Or advanced degree with a minimum of 2 years of Regulatory Affairs experience within the medical device industry
• Medical device industry experience with Class I/II/III/IV software products
• Direct Regulatory Affairs experience supporting programs throughout software development life cycle (Nice To Have)
• Experience performing advertising and promotion reviews/approvals for medical devices (Nice To Have)
• Experience in leading early interactions with regulatory authorities (Nice To Have)
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) (Nice To Have)
• Working knowledge of Project Management methodologies and tools; PMP certification is an asset (Nice To Have)
• Demonstrated strong business acumen and planning (Nice To Have)
• Strong interpersonal, quantitative analysis, and problem-solving skills (Nice To Have)
• High degree of initiative and influence management skills (Nice To Have)
• Results oriented (Nice To Have)
• Ability to drive to completion in adherence to aggressive project schedules (Nice To Have)
• Ability to manage multiple projects and proficiency with Microsoft Office and software tools (Nice To Have)

Core Competencies

Demonstrates expertise in developing and executing global regulatory strategies for medical devices, including software-based solutions. Proficient in leading regulatory submissions and agency interactions while ensuring compliance with FDA, EU MDR, NMPA, PMDA, and TGA requirements.

Highest-signal resume keywords

• Regulatory Affairs Experience
• Medical Device Industry Knowledge
• Global Regulatory Strategy Development
• Regulatory Submissions Leadership
• Cross-Functional Team Collaboration

ATS Optimization Keywords

Hard Skills

• Regulatory Strategy Development
• Regulatory Submissions
• Risk Assessment
• Regulatory Pathway Identification
• Advertising and Promotion Review
• Software Development Life Cycle
• Project Management Methodologies
• Quantitative Analysis
• Problem-Solving
• Regulatory Compliance

Soft Skills

• Interpersonal Skills
• Influence Management
• Initiative
• Results Orientation
• Communication

Certifications & Qualifications

• PMP Certification

Industry Keywords

• FDA
• EU MDR
• NMPA
• PMDA
• TGA
• 510(k)
• PMA
• IDE
• CE Mark
• Medical Device Class I/II/III/IV

Tools & Technologies

• Microsoft Office
• Regulatory Submission Tools
• Project Management Tools