Regulatory Affairs Associate

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Assist in global registrations to ensure that medical devices manufactured by Venus Concept comply with regulatory standards in the markets where they are sold.

• Implement regulatory strategies that support the registration and commercialization of medical devices.

• Prepare and submit technical documentation, design dossiers, and other regulatory applications for regions outside the United States.

• Collaborate with in-country regulatory partners and consultants to fulfill local requirements and uphold registrations in good standing.

• Offer regulatory advice and support to cross-functional teams on global market issues.

• Keep track of changes in global regulatory requirements and industry standards, and relay updates internally.

• Ensure that regulatory submissions are of high quality, complete, and submitted in a timely manner.

• Maintain and apply knowledge of international regulations, standards, and guidelines.

• Assist in formulating regulatory strategies for Venus Concept.

• Report directly to the Regulatory Affairs Manager.

⛳️ Requirements

• A Bachelor's degree in a scientific or technical field.

• 2-5 years of experience in regulatory affairs, specifically focusing on global medical device registrations.

• Familiarity with global regulations and standards pertaining to medical devices.

• Experience in developing and implementing global regulatory strategies.

• Proven experience in preparing and submitting regulatory applications.

• Proficient in handling technical documentation, including design dossiers, technical files, and other regulatory submissions.

• Exceptional organizational skills and attention to detail.

• Capability to work accurately in a dynamic, fast-paced environment.

• Ability to work remotely.

• Strong communication and interpersonal skills.

• Competence in a team setting, able to communicate effectively with stakeholders at all levels of the organization.

• Proficiency in the English language is mandatory.

• Professional proficiency in Microsoft Office is required.

🏝️ Benefits

• Comprehensive benefits package beginning on Day 1.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• 401(k) matching.

• Commitment to equal opportunity, diversity, and inclusion.

• Disability accommodations available throughout every stage of the recruitment process.

• Flexible remote work arrangement.