Regulatory Affairs Associate

Venus AI•Boston, MA

About The Position

Venus Concept is seeking a highly motivated, results-driven Regulatory Affairs Associate to support global registrations and ensure that its medical devices meet regulatory requirements in the countries where they are marketed. The role executes regulatory strategies, prepares and submits regulatory documents, and provides regulatory guidance to cross-functional teams working with global markets. It coordinates with in-country regulatory partners and consultants, monitors changes in international requirements and standards, and helps develop regulatory strategies. The position is based in Boston, Massachusetts, and the qualifications state that the candidate must be able to work remotely.

Requirements

Bachelor’s degree in a scientific or technical discipline.
2–5 years of experience in regulatory affairs, focused on global medical device registrations.
Knowledge of global medical device regulations and standards.
Experience 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, changing environment.
Ability to work remotely.
Excellent communication and interpersonal skills.
Ability to work in a team and communicate with stakeholders across all levels of the organization.
English language proficiency.
Professional experience using Microsoft Office.

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 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 guidance and support to cross-functional teams on regulatory matters related to global markets.
Monitor changes in global regulatory requirements and industry standards, and communicate changes to the organization.
Ensure regulatory submissions are high quality, complete, and timely.
Maintain knowledge of international regulations, standards, and guidance documents and apply it to global regulatory strategies and submissions.
Assist in developing regulatory strategies for Venus Concept.