Senior Regulatory Specialist

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

📋 Description

• Provide regulatory support for product development teams.

• Draft regulatory opinion documents.

• Oversee labeling activities.

• Review and authorize design control documentation, risk management reports, technical protocols and reports, as well as other outputs from product development.

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

• Track global regulatory and product modifications and lead impact assessments.

• Maintain assigned metrics, including the preparation, monitoring, and trending of reports.

• Assist with audits and offer timely feedback to stakeholders.

• Foster and sustain effective relationships with both internal and external stakeholders.

• Contribute to the company's and department's quality and business goals and initiatives.

• Report on metrics related to assigned projects.

• Perform additional duties as required.

⛳️ Requirements

• Bachelor’s degree.

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

• Understanding of 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.

• Experience in technical writing.

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

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

• Frequent (>75%) fine motor manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.).

• Remote positions necessitate a home office setting with minimal distractions.

🏝️ Benefits

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

• Paid Time Off (PTO).

• 401(k) matching.

• Holiday compensation.

• Medical, dental, and vision insurance.

• Coverage for short-term and long-term disability.

• Paid parental leave.

• Remote work options available.

• A workplace culture certified as a Great Place to Work®.