Regulatory Affairs Associate

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.

What you will be part of – our Venus Culture

Venus believes in pushing boundaries while embracing creativity and innovation. Our employees are a critical part of our company’s performance and are at the core of its success. At Venus, we rely on our employees, customers, and network of industry professionals around the world to continuously improve and Deliver the Promise. In order to do that, we ensure that everyone operates with the same values and vision. At Venus, we promise to give you Endless Opportunities, allow you to Foster Innovation and be part of Delivering a Best-In-Class Offering.

Venus is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. Venus is committed to accommodating persons with disabilities. Accommodation is available on request for qualified candidates during each stage of the recruitment process.

About Venus Concept

Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 10 direct markets. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, Venus Epileve, Venus Viva MD and AI.ME. Venus Concept's hair restoration systems include NeoGraft® and the ARTAS iX® Robotic Hair Restoration system. Venus Concept has been backed by leading healthcare industry growth equity investors, including EW Healthcare Partners (formerly Essex Woodlands), HealthQuest Capital, Longitude Capital Management, Aperture Venture Partners, and Masters Special Situations.