Regulatory Affairs Specialist

About the Company

Vectra is a talent and consulting firm that focuses on creating connections that empower people and strengthen organizations. With expertise across IT, healthcare, and non-technical fields, Vectra provides flexible staffing, consulting, and recruitment services designed to help companies excel in competitive markets. Operating worldwide including the USA, UK, Canada, UAE, Europe, and India, Vectra emphasizes quality, innovation, and lasting partnerships. Recognized as a Best Place to Work and noted by USA News for its innovative approach, Vectra is a certified global recruitment and career development partner.

Role Overview

This full-time position based on-site in Boston, MA, involves acting as a Regulatory Affairs Specialist. Responsibilities include preparing and overseeing regulatory submissions, ensuring the company complies with applicable regulations, and maintaining thorough regulatory documents. The role requires monitoring regulatory updates, cross-departmental collaboration, and providing expert guidance to ensure compliance. Key traits for success include keen attention to detail, strong communication capabilities, and excellent organizational skills.

Key Responsibilities

• Prepare and manage regulatory filings and submissions adhering to all relevant standards and deadlines.
• Maintain and organize precise regulatory documentation to ensure compliance.
• Monitor evolving regulatory requirements and recommend necessary adjustments.
• Collaborate effectively with various teams to support compliance activities.
• Guide teams and stakeholders on regulatory compliance matters.

Qualifications and Requirements

• Solid expertise in creating, organizing, and maintaining regulatory documentation.
• Thorough understanding of regulatory compliance guidelines and industry standards.
• Experience managing regulatory affairs and meeting local, national, and international regulatory demands.
• Proven record of timely and accurate regulatory submissions.
• Excellent communication, analytical reasoning, and problem-solving abilities.
• Ability to work collaboratively in teams and skillfully prioritize tasks amidst competing demands.
• Bachelor’s degree required in Life Sciences, Pharmacy, Regulatory Affairs or related disciplines; advanced degree preferred.
• Previous regulatory affairs experience in pharmaceutical, healthcare, or medical device fields is highly valued.