Quality Analyst – Regulatory Compliance Specialist

Position Overview

This position supports the Regulatory Compliance team and assists with regulatory compliance activities. The role performs various tasks related to Regulatory Compliance and the Quality Management System (QMS).

Responsibilities

• Ensure regulatory compliance records are accurate, complete, and maintained according to applicable requirements.
• Prepare, review, and maintain quality system and regulatory compliance documentation.
• Maintain and update compliance-related database records.
• Support QMS document control processes.
• Assist with creation, maintenance, and updating of training materials and training audiences.
• Identify discrepancies between metadata fields and approval records.
• Update required fields in electronic systems to ensure alignment with approval records.
• Learn and navigate electronic systems used to manage records and data.
• Maintain detail-oriented and organized work practices.
• Assist in developing and executing business systems to identify and resolve quality issues.
• Apply problem-solving methodologies to prioritize and resolve quality concerns.
• Support Quality Management System initiatives and compliance activities.
• Follow FDA regulations, regulatory requirements, company policies, and procedures.
• Collaborate professionally with internal teams, customers, contractors, and vendors.
• Perform additional duties as assigned.

Required Experience

• 2–5 years of quality and/or regulatory experience, OR
• 2+ years of relevant industrial experience in quality, product development/support, or scientific affairs.

Required Skills

• Knowledge of regulations and standards affecting medical devices.
• Strong attention to detail and organizational skills.
• Ability to learn new systems and processes quickly.
• Experience with quality systems and documentation management preferred.

Education

Bachelor’s degree preferred in:

• Biotechnology
• Biology
• Chemistry
• Engineering
• Related scientific discipline

Additional Details

• Interview process: Initial Teams interview, followed by onsite visit or second Teams interview.
• Candidate must be able to start ASAP after completion of screenings.

Pay: $36.00 - $38.00 per hour

Work Location: In person