QA & Regulatory Affairs Manager — Med Device (SaMD)

Jobgether; United States; Remote; USD 101,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental & vision

Paid time off

401(k) match

Parental leave

Life & disability insurance

EAP & wellness programs

Professional development

Job summary

Jobgether is seeking an experienced regulatory affairs professional to lead quality systems and compliance for SaMD risk management and post‑market monitoring. You will work with cross‑functional teams across product development, auditing, and regulatory submissions to uphold ISO 13485, MDSAP, MDR and related standards.

The role requires interpreting FDA guidance and international regulations, managing CAPA and audits, and driving continuous improvement in a fast‑paced medical device

Qualifications

• 5+ years in Quality Assurance and Regulatory Affairs in the medical device industry.
• Experience interpreting FDA guidance and international regulatory requirements.
• Knowledge of MDSAP, MDR, UKCA, ISO 13485, and QMSR.
• Experience managing QMS activities including CAPA, complaints, audits, and post‑market surveillance.
• Excellent communication and cross‑functional collaboration skills.

Responsibilities

• Develop, implement, and maintain QSDs to ensure FDA and international compliance.
• Support external audits and inspections by notified bodies and regulators.
• Collaborate with NPD and EPE teams across the product lifecycle for DHF, Technical Files, and risk management.
• Participate in nonconforming product and complaint processes; document, investigate, and resolve issues.
• Lead CAPA initiatives to address systemic quality issues and drive continuous improvement.
• Coordinate internal and supplier audits per programs and regulations.
• Monitor CAPA, complaints, clinical evaluation, and post-market data; prepare management reports.
• Maintain ISO 13485:2016, MDSAP, MDR, UKCA, and CMDCAS registrations; build regulatory knowledge base.

Skills

Regulatory compliance

Quality management

Regulatory audits

CAPA

Risk assessment

Documentation

Cross-functional collaboration

Regulatory strategy

Regulatory knowledge

Education

Bachelor's degree in Healthcare/Quality/IT

Job description

Jobgether is seeking an experienced regulatory affairs professional to lead quality systems and compliance for SaMD risk management and post‑market monitoring. You will work with cross‑functional teams across product development, auditing, and regulatory submissions to uphold ISO 13485, MDSAP, MDR and related standards.

The role requires interpreting FDA guidance and international regulations, managing CAPA and audits, and driving continuous improvement in a fast‑paced medical device