Senior Regulatory Specialist

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

📋 Description

• Provide regulatory support to product development teams.

• Draft regulatory opinion documents.

• Oversee labeling activities.

• Evaluate and authorize design control documentation, risk management reports, technical protocols and reports, as well as other product development deliverables.

• Create, review, and authorize labeling, advertising, and promotional materials to ensure alignment with approved claims and regulatory standards.

• Stay informed about global regulatory and product changes and lead impact assessments accordingly.

• Manage assigned metrics, which includes preparing, tracking, and trending reports.

• Assist with audits and provide timely feedback to relevant stakeholders.

• Build and maintain strong relationships with both internal and external stakeholders.

• Contribute to the company and departmental quality and business objectives and initiatives.

• Report on assigned project metrics.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree required.

• Minimum of 6 years of experience as a regulatory specialist in a related medical device or pharmaceutical sector.

• Familiarity with FDA, EU, and other regulatory body regulations.

• Regulatory Affairs Certification (RAC) is preferred.

• AATB CTBS certification is preferred.

• Exceptional verbal and written communication skills.

• Proficiency in Microsoft Office Suite.

• Skills in technical writing.

• Capability to move or lift objects weighing up to 25 pounds.

• Frequent (>75%) stationary position (standing or sitting) while using digital displays.

• Frequent (>75%) fine manipulation using hands and fingers.

🏝️ Benefits

• Annual bonus opportunity of up to $10,000.

• Paid Time Off (PTO).

• 401(k) match.

• Holiday pay.

• Medical, dental, and vision insurance.

• Short-term and long-term disability coverage.

• Paid parental leave.

• Remote work options.

• Home office environment designed for minimal distractions.