Developing and executing regulatory strategies for new and modified medical devices in line with business objectives
Manage regulatory associates as needed, responsible for team’s work planning, guidance, execution and talent development
Lead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products
Key Regulatory SME and review & approve advertising and promotional materials to ensure regulatory compliance
Regulatory strategy and processes for product life cycle management
Lead EU MDR Technical Documentation and other international submissions for both wearable devices and SaMD
Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed
Lead regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance
Preparing international and domestic regulatory filings/registrations in line with established project timelines
Interacting with regulatory authorities during the development and review process to ensure submission clearance
Review and approve product design changes to maintain regulatory compliance for significant changes
Author or revise SOPs to improve regulatory compliance within the Quality System
Monitoring the impact of changing global regulations on submission strategies & registrations
Support external and internal audits
Perform other regulatory-related duties as assigned.

Requirements

BA or BS degree in engineering, life sciences, or a related field required
> 8-10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree
6 years minimum of US and/or EU regulatory affairs experience with a Master’s degree
Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA and other medical device industry standards
Software as a medical device (SaMD) experience required
New product development experience required
Authorship of 510(k)s and experience with management of FDA reviews to gain clearance required
Demonstrated competency in developing risk based regulatory strategies required
Wearable medical device experience preferred
Familiarity with global medical device regulations (LATAM, Asia Pac, EMEA, etc.) preferred
Audit support experience preferred
Strong project management skills
Exceptional problem-solving skills
Exceptional organizational skills
Exceptional communication (written and oral) skills
Willingness to travel when required, approximately 5-10%

Benefits

medical, dental and vision insurance
paid holidays
paid time off
401K (w/ company match)
Employee Stock Purchase Plan
annual organizational/cultural committee events

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategiesFDA submissions510(k)SaMDEU MDR Technical Documentationregulatory filingsSOPsrisk based regulatory strategiesnew product developmentregulatory compliance

Soft Skills

project managementproblem-solvingorganizational skillscommunication skillsteam managementtalent developmentcollaborationguidanceexecutioninterpersonal skills

Certifications

BA or BS degreeMaster’s degree