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Prime Path Medtech™ · 5 days ago

Regulatory Associate

United States

Part-time

Remote

Mid Level

$65K/yr - $70K/yr

3+ years exp

Prime Path Medtech, Inc. is a growing, established medical device company dedicated to advancing healthcare through cutting-edge technology. They are seeking an experienced Regulatory Associate to contribute to product maintenance and new product development initiatives, requiring broad regulatory expertise across multiple global markets.

Artificial Intelligence (AI)Clinical TrialsTraining

Responsibilities

Prepare, compile, and submit regulatory applications and notifications to FDA, EU regulatory bodies, and other international authorities

Support both pre-market submissions (510(k), PMA, De Novo, EU MDR/IVDR) and post-market surveillance activities

Maintain regulatory intelligence on evolving global medical device regulations and standards

Manage regulatory documentation and ensure compliance with FDA QSR, ISO 13485, and other applicable standards

Coordinate responses to regulatory agency questions and requests for additional information

Support design control activities and ensure regulatory requirements are integrated into product development

Collaborate with cross-functional teams including R&D, quality, clinical, and project management

Maintain regulatory files and databases for existing and new products

Conduct regulatory assessments for product changes and modifications

Support regulatory strategy development for new products and market expansions

Assist with software regulatory submissions and documentation (software as a medical device experience is a plus)

Monitor and report on post-market requirements including adverse events and recalls

Qualification

Regulatory affairs experienceFDA regulations knowledgeISO 13485 knowledgeRegulatory submission systemsProject management skillsCommunication skillsDetail-orientedOrganizational abilitiesWork independently

Required

Bachelor's degree in life sciences, engineering, or related field

3-7 years of regulatory affairs experience in the medical device industry

Strong knowledge of FDA regulations (21 CFR Part 820), EU MDR/IVDR, and ISO 13485

Experience with multiple regulatory pathways including 510(k), PMA, De Novo, and international submissions

Understanding of quality management systems and design controls

Excellent written and verbal communication skills

Strong project management and organizational abilities

Detail-oriented with ability to manage multiple projects simultaneously

Proficiency with regulatory submission systems and document management tools

Ability to work independently in a remote environment

Preferred

Advanced degree

Familiarity with software regulatory requirements (IEC 62304, cybersecurity)

Software as a medical device experience

Benefits

Remote work flexibility

Opportunity to work with cutting-edge medical device technology across diverse product portfolios

Collaborative team environment that values regulatory expertise and strategic thinking

Strong opportunities for professional growth and career advancement in regulatory affairs

Exposure to both domestic and international regulatory pathways

Company

Prime Path Medtech™

We partner with companies at all stages to achieve business outcomes – from strategic regulatory planning to all phases of the product development process to get your product on the market.

Founded in 2017

Minneapolis, Minnesota, USA

11-50 employees