Regulatory Affairs Associate

Venus AI LLC

. Support global registrations and ensure medical devices produced by Venus Concept meet regulatory requirements in countries where devices are marketed .

Posted 10/26/2026full-timeRemote • Massachusetts • United StatesJuniorMid-Level💰 $85,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory affairs for medical devices, including the preparation and submission of technical documentation and regulatory filings. Proficient in developing global regulatory strategies and maintaining compliance with international regulations and standards.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Medical Device RegistrationsRegulatory Strategy DevelopmentTechnical Documentation PreparationKnowledge of Global Regulations

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

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

Hard Skills

Regulatory FilingsTechnical FilesDesign DossiersGlobal Regulatory StrategiesRegulatory Submissions

Soft Skills

Excellent OrganizationAttention to DetailExcellent CommunicationInterpersonal SkillsTeam Collaboration

Tools & Technologies

Microsoft Office

Industry Keywords

Medical Device RegulationsInternational RegulationsRegulatory GuidanceCross-Functional Team SupportRegulatory Compliance

About the role

Key responsibilities & impact

Support global registrations and ensure medical devices produced by Venus Concept meet regulatory requirements in countries where devices are marketed
Execute regulatory strategies supporting registration and commercialization of medical devices
Prepare and submit technical files, design dossiers, and other regulatory filings for countries outside the United States
Coordinate with in-country regulatory partners and consultants to meet local requirements and maintain registrations in good standing
Provide regulatory guidance and support to cross-functional teams on global-market matters
Monitor changes in global regulatory requirements and industry standards and communicate updates internally
Ensure regulatory submissions are high quality, complete, and timely
Maintain and apply knowledge of international regulations, standards, and guidance documents
Assist in developing regulatory strategies for Venus Concept
Report to the Regulatory Affairs Manager

Requirements

What you’ll need

Bachelor's degree in a scientific or technical discipline
2-5 years of experience in regulatory affairs, with a focus on global medical device registrations
Knowledge of global regulations and standards for medical devices
Experience developing and executing global regulatory strategies
Experience preparing and submitting regulatory filings
Experience with technical documentation, including design dossiers, technical files, and other regulatory submissions
Excellent organization and attention to detail
Ability to work accurately in a fast-paced, ever-changing environment
Ability to work remotely
Excellent communication and interpersonal skills
Ability to work in a team environment and communicate with stakeholders across all levels of the organization
English language proficiency required
Professional experience proficiency with Microsoft Office required

Benefits

Comp & perks

Comprehensive benefits package starting on Day 1
Medical insurance
Dental insurance
Vision insurance
Life insurance
401(k) match
Equal opportunity, diversity, and inclusion commitment
Disability accommodations during each stage of the recruitment process
Remote work arrangement