Regulatory Affairs Associate

Job not on LinkedIn

🔥 6 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $85k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Venus AI LLC

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2023

💼 Consulting

📣 Marketing

🤖 Artificial Intelligence

Consulting • Marketing • Artificial Intelligence

Venus AI LLC is an artificial intelligence-focused company that develops and deploys AI-driven solutions and services. With an emphasis on applying machine learning and data-driven techniques, the company helps organizations automate workflows, derive insights from data, and enhance decision-making. Venus AI LLC may offer consulting, model development, and integration support to enterprise and SMB clients seeking to adopt AI technologies.

📋 Description

• 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

• 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

• 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