Join our Facebook group
👉 Remote Jobs Network
pfm medical, inc.
pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1
Medical Device Manufacturing
11 - 50
Associate Director - GCP Quality and Compliance
August 21
pfm medical, inc.
pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1
Medical Device Manufacturing
11 - 50
Description
• Support the audit program and clinical projects to ensure compliance with regulations and Precision procedures. • Perform ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations. • Lead the oversight of a Quality Management Systems inclusive of SOPs, Training and CAPAs. • Audit regulatory documents for submission to the FDA and global regulatory authorities. • Provide ICH/GCP guidance, auditing advice and training to internal and external clients.
Requirements
• 8-10 years of experience in clinical research or pharmaceutical development with emphasis in Quality Assurance/Compliance • Working knowledge of GCP/ICH guidelines and FDA regulations • Bachelor’s degree in a science, healthcare or related field of study • Availability to travel up to 25% domestically and/or internationally • Graduate, postgraduate degree, ideally in a scientific or healthcare discipline (preferred) • CRO, Pharmaceutical and/or Medical device experience (preferred) • Supervisory/management experience (preferred)
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation
Apply NowSimilar Jobs
August 21
Precision Medicine Group
1001 - 5000
Ensure compliance during clinical trials and support quality initiatives for therapeutics.
🇺🇸 United States – Remote
💵 $125.2k - $187.8k / year
💰 $35.2M Venture Round on 2021-03
⏰ Full Time
🟠 Senior
🚔 Compliance
🗽 H1B Visa Sponsor
August 20
The Symicor Group
2 - 10
Coordinate compliance program implementation and administration for a bank's operations.
August 20
Samsara
1001 - 5000
Oversee safety and compliance certification processes for electrical and electronic equipment.
August 17
Zeta
1001 - 5000
Manage compliance oversight for credit card portfolios at a banking tech company.
August 16
Toast
1001 - 5000
Mature the Enterprise Risk and Compliance program for restaurant platform services.