Remote Medical Device Quality & Regulatory Expert

Pharmavise Corporation; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

PharmaviseConsulting Corp. is hiring a Medical Device Quality and Compliance Expert for a remote role in the United States. You will lead QMS activities, develop compliance strategies, and support regulatory submissions with FDA and notified bodies.

Ideal candidates hold a bachelor’s in engineering or life sciences, 8+ years in medical device quality/regulatory roles, and strong ISO 13485, FDA QSR, and EU MDR knowledge. Excellent communication and cross-functional leadership are essential.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field.
• Minimum of 8 years in quality assurance and regulatory compliance in medical devices.
• In-depth knowledge of ISO 13485, FDA QSR, and EU MDR.
• Experience leading QMS implementations and maintaining compliance in regulated environments.
• Strong understanding of ISO 14971 risk management principles.
• Excellent communication and interpersonal skills for regulatory discussions.

Responsibilities

• Lead and oversee QMS activities for medical device products across the lifecycle.
• Develop and implement quality and compliance strategies per ISO 13485, FDA QSR, MDR.
• Conduct risk assessments and mitigation for quality and compliance issues.
• Provide guidance on regulatory submissions and regulatory agency interactions.
• Lead and support internal and supplier audits and regulatory inspections.
• Collaborate cross-functionally with R&D, manufacturing, regulatory affairs to meet objectives.
• Stay updated on regulatory trends and update QMS processes accordingly.

Skills

Quality assurance

Regulatory compliance

QMS leadership

ISO 13485

FDA QSR

EU MDR

Risk management

Audits

Cross-functional leadership

Education

Bachelor’s in engineering, life sciences, or related field

Job description

PharmaviseConsulting Corp. is hiring a Medical Device Quality and Compliance Expert for a remote role in the United States. You will lead QMS activities, develop compliance strategies, and support regulatory submissions with FDA and notified bodies.

Ideal candidates hold a bachelor’s in engineering or life sciences, 8+ years in medical device quality/regulatory roles, and strong ISO 13485, FDA QSR, and EU MDR knowledge. Excellent communication and cross-functional leadership are essential.