Regulatory Affairs Lead

Genesis MedTech Group; United States; Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Annual performance bonus

Comprehensive benefits package

Flexible remote work

Job summary

Genesis MedTech Group seeks a Regulatory Affairs Lead to direct US regulatory strategy and FDA submissions for an advanced surgical medical device portfolio. You will own submission timelines, author complex filings, and lead agency interactions across cross-functional teams to drive development and commercialization.

The role includes end-to-end submission work, strategic pre-submission planning, and collaborating with global teams to align development and compliance timelines.

Qualifications

• Experience directing regulatory strategy for medical devices.
• Strong ability to author FDA submissions and manage timelines.
• Experience with GLP animal studies and human factors in submissions.

Responsibilities

• End-to-end submission authoring and timeline ownership.
• Act as primary FDA liaison for assigned products and meetings.
• Provide regulatory input to New Product Development and testing strategies.
• Assess design changes and determine regulatory pathways and exemptions.
• Coordinate global regulatory alignment for multiple markets.

Skills

Regulatory strategy

FDA submissions

Cross-functional leadership

Independent work

Project management

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Advanced degree in Engineering or Life Sciences

Job description

The Regulatory Affairs Lead directs U.S. regulatory strategy and submissions for an advanced surgical medical device portfolio. This individual is responsible for guiding products through FDA regulatory pathways, driving agency interactions, and partnering with cross-functional teams to support product development and commercialization. The role combines strategic leadership with hands-on submission authoring and execution.

This role will drive US regulatory clearances end to end, from pre-submission strategy through 510(k)/De Novo authoring and agency negotiation, while partnering closely with global cross-functional teams to keep product development and compliance timelines aligned.

Location & Travel Requirements

This position offers flexibility for remote work within the United States. The successful candidate will be expected to travel up to 20% of the time, including both domestic and international travel, based on business needs and the candidate's location. Travel may include visits to company sites, cross-functional meetings, and occasional trips to China to support regulatory activities, collaboration, and key business objectives. Candidates should be flexible and willing to travel as needed to effectively support the role and the organization.

Job Duties and Key Responsibilities:

End-to-End Submission Authoring

• Independently lead and author FDA submissions while collaborating with internal subject matter experts and cross-functional stakeholders.
• Own the submission timeline and content quality from predicate/comparator strategy through final agency clearance.

FDA Interaction & Negotiation

• Act as the primary liaison with FDA for assigned products. Independently construct Q-Submission (Pre-Sub) briefing packages, lead agency meetings, and resolve Additional Information (AI) deficiency letters through sound scientific and regulatory justification.

Product Development Support

• Serve as the regulatory lead on New Product Development (NPD) core teams, providing strategic input on testing protocols including GLP animal studies, human factors/usability validation (including for robotic systems), biocompatibility evaluation, and bench testing (e.g., burst pressure testing for energy-based devices).

Regulatory Assessment & Scientific Rationale

• Evaluate proposed design changes and determine appropriate regulatory pathways and testing scope, including building sound scientific rationale for testing exemptions where applicable.

Global Alignment

• Produce FDA submission packages and testing rationales of sufficient rigor and clarity to be leveraged by the Global Regulatory Affairs team for other markets, including EU MDR, Japan PMDA, China NMPA, and Singapore HSA, etc.
• Provide leadership through expertise, influence, and collaboration, serving as a trusted regulatory partner to cross-functional teams and business leaders. As the organization grows, this role is expected to contribute to building organizational capability, strengthening regulatory processes, and supporting the development of future talent and team structures.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical field
• Typically requires 8+ years of progressive Regulatory Affairs experience within the medical device industry
• Deep working knowledge of Class II/III medical device regulations
• Strong ability to interpret complex non-clinical study reports and engineering rationale
• Direct experience managing Human Factors and GLP animal study requirements in support of FDA submissions
• Demonstrated ability to operate independently in a fast-paced environment, comfortable functioning as both strategic lead and tactical executor on the same project

Preferred qualifications:

• Advanced degree in Engineering, Life Sciences, or a related technical field
• 10+ years of dedicated Regulatory Affairs experience in the medical device industry
• Surgical robotics background
• Energy-based device experience
• Direct submission experience in one or more of the following):
• -Active surgical equipment and energy platforms (e.g., ultrasonic scalpels, advanced vessel-sealing devices)
• -Surgical robotics or other complex capital medical equipment
• -Advanced surgical instruments, including surgical stapling systems

Pay Range and Compensation Package

Base Salary Range: $140,000 - $200,000 annually.

Actual compensation will be determined based on factors including experience, qualifications, skills, geographic location, and business needs. In addition to base salary, this position is eligible for an annual performance bonus and a comprehensive benefits package.

Equal Opportunity Statement

Genesis MedTech provides reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state and local laws. Applicants who require an accommodation during the application or interview process should contact Human Resources.

Genesis MedTech is an Equal Opportunity Employer. We are committed to fostering an inclusive workplace and providing equal employment opportunities to all employees and applicants. Employment decisions are made without regard to race, color, religion, creed, sex, pregnancy, childbirth, or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, veteran status, military status, citizenship status, or any other characteristic protected by applicable federal, state, or local law.