Regulatory Specialist

ACE Partners; Charlotte (NC); On-site; USD 70,000 - 92,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Pension plan

Paid maternity leave

Child care support

Paid paternity leave

Disability insurance

Job summary

ACE Partners is seeking a Regulatory Specialist to ensure compliance in the medical device sector. This role includes managing recalls, regulatory submissions, and audits, requiring solid experience and understanding of FDA regulations and standards. The position offers a full-time contract with competitive compensation and excellent benefits.

Qualifications

• 5–8 years of experience in the life sciences industry, preferably medical devices.
• Demonstrated expertise in medical device recalls and MDRs.
• Familiarity with FDA regulations (21 CFR 803, 806, 820, 830) and ISO 13485.

Responsibilities

• Lead the preparation of MDRs, MPRs, and recalls.
• Serve as the SME during regulatory audits and inspections.
• Collaborate with global regulatory teams and authorities.

Skills

Regulatory writing

Complaint handling

Trend analysis

Communication

Education

Bachelor’s degree in a scientific or healthcare-related field

Tools

FDA eSubmitter

ESG platforms

Job description

This range is provided by ACE Partners . Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70,000.00/yr - $92,000.00/yr

Direct message the job poster from ACE Partners

Empowering the Next Generation of Vascular MedTech with Top Talent

Job Title: Regulatory Specialist

Overview:

This role is responsible for ensuring regulatory compliance by managing recalls, medical device reports (MDRs/MPRs), and critical complaints. The Specialist will lead regulatory submissions, liaise with authorities, and support corrective actions in alignment with FDA, ISO, and other global standards.

Key Responsibilities:

• Develop and maintain procedures for recalls, MDR/MPR, and complaint handling.
• Lead the preparation and submission of MDRs, MPRs, recalls, and FSCAs.
• Serve as the SME during regulatory audits and inspections.
• Maintain effective communication with internal teams and external stakeholders.
• Ensure accurate and timely regulatory submissions and documentation.
• Prepare and coordinate customer notifications and field corrections.
• Collaborate with global regulatory teams and support regulatory authority interactions (FDA, Health Canada, etc.).
• Oversee corrections, removals, and recalls.
• Drive investigations and trend analysis for critical complaints.
• Generate statistical reports to identify systemic issues.

Qualifications:

• 5–8 years of experience in the life sciences industry, preferably medical devices.
• Bachelor’s degree in a scientific or healthcare-related field (preferred).
• Demonstrated expertise in medical device recalls, MDRs, and complaint handling.
• Strong regulatory writing and submission experience.
• Familiarity with FDA regulations (21 CFR 803, 806, 820, 830) and ISO 13485/14971.
• Experience with FDA eSubmitter and ESG platforms.
• Solid understanding of Quality Management Systems in regulated environments.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal and Quality Assurance

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Pension plan

Paid maternity leave

Child care support

Paid paternity leave

Disability insurance

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