Bachelor's degree in a scientific or technical discipline.
2-5 years of experience in regulatory affairs, focusing on global medical device registrations.
Knowledge of global regulations and standards for medical devices.
Experience in developing and executing global regulatory strategies.
Proficient in preparing technical documentation like design dossiers and regulatory submissions.
Excellent organizational skills and attention to detail.
Strong communication and interpersonal skills.
Responsibilities
Execute regulatory strategies for medical device registration and commercialization.
Prepare and submit regulatory documents for international markets.
Coordinate with in-country regulatory partners to meet local requirements.
Provide regulatory guidance to cross-functional teams.
Stay updated on global regulatory changes and communicate them internally.
Ensure high-quality, complete, and timely regulatory submissions.
Maintain knowledge of international regulations and apply it to strategies.
Benefits
Comprehensive benefits package starting on Day 1.
Coverage for medical, dental, and vision insurance.
Life insurance included.
401(k) match available.
Full Job Description
Title: Regulatory Affairs Associate
Reporting to: Regulatory Affairs Manager
Location: Boston, Massachusetts, USA
We are seeking a highly motivated and results-driven Regulatory Affairs Associate to join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ensuring that medical devices produced by Venus Concept meet all regulatory requirements for countries where the devices are marketed. This role is responsible for executing regulatory strategies, preparing and submitting regulatory documents, and providing guidance and support to cross-functional teams on regulatory matters related to global markets.
Responsibilities:
Execute regulatory strategies to support the registration and commercialization of medical devices in compliance with global regulatory requirements.
Prepare and submit regulatory documents, including technical files, design dossiers, and other regulatory filings as required for countries outside the United States.
Coordinate with in-country regulatory partners and consultants to ensure that all local regulatory requirements are met and all registrations are maintained in good standing.
Provide guidance and support to cross-functional teams on regulatory matters related to global markets.
Stay up-to-date with changes in global regulatory requirements and industry standards, and communicate these changes to the organization.
Ensure that all regulatory submissions are of high quality, complete, and timely.
Maintain knowledge of international regulations, standards, and guidance documents and apply that knowledge to global regulatory strategies and submissions.
Assist in the development of regulatory strategies for Venus Concept.
Qualifications:
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 in developing and executing global regulatory strategies and 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 remote
Excellent communication and interpersonal skills.
Ability to work in a team environment and communicate with stakeholders across all levels of the organization.
Language proficiency required; English
Professional experience proficiency required with Microsoft Office
Compensation:
Base salary range: $85,000
Benefits: Comprehensive package starting on Day 1, covering medical, dental, vision, life insurance, and a 401(k) match, among other benefits.
