Remote Medical Device Quality & Regulatory Expert

Pharmavise Corporation; Poland; Remote; PLN 180,000 - 260,000; Full time

Job summary

Pharmavise Consulting Corp. is seeking Medical Device Quality and Compliance Experts to help clients navigate ISO 13485, FDA QSR, and MDR across development to commercialization.

This is a remote position, allowing you to work with pharmaceutical, medical device, and biotechnology partners worldwide. You will lead QMS activities, guide regulatory submissions, perform risk assessments, and coordinate internal and supplier audits while mentoring cross-functional teams to uphold patient safety and

Qualifications

• Bachelor's degree in engineering, life sciences, or related field is required; advanced degree preferred.
• Minimum of 8 years of experience in quality assurance and regulatory compliance within the medical device industry.
• In-depth knowledge of ISO 13485, FDA QSR, and EU MDR.
• Experience leading QMS implementations and maintaining compliance in a regulated environment.
• Strong understanding of risk management principles (e.g., ISO 14971).
• Excellent communication and interpersonal skills; ability to explain complex regulatory requirements.

Responsibilities

• Lead and oversee QMS activities for medical device products across the product lifecycle.
• Develop and implement quality and compliance strategies to meet regulatory requirements and guidelines (ISO 13485, FDA QSR, MDR).
• Conduct risk assessments and mitigation to address quality and compliance issues.
• Provide guidance on regulatory submissions and interactions with regulatory agencies (FDA, notified bodies).
• Lead and support internal and external audits, including supplier audits and regulatory inspections.
• Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and other teams.
• Stay updated on regulatory trends and implement updates to QMS processes as needed.

Skills

Quality Management System

Regulatory Compliance

Auditing

Cross-functional Collaboration

Regulatory Submissions

Risk Management

Communication

Education

Bachelor's degree in engineering, life sciences, or related field

Advanced degree

Job description

Pharmavise Consulting Corp. is seeking Medical Device Quality and Compliance Experts to help clients navigate ISO 13485, FDA QSR, and MDR across development to commercialization.

This is a remote position, allowing you to work with pharmaceutical, medical device, and biotechnology partners worldwide. You will lead QMS activities, guide regulatory submissions, perform risk assessments, and coordinate internal and supplier audits while mentoring cross-functional teams to uphold patient safety and