Job Summary
A company dedicated to making global impact by improving patient care is searching for a person to fill their position for a Remote Regulatory Affairs and Quality Assurance Head.
Core Responsibilities Include:
- Designing and implementing company’s QMS
- Developing, writing, maintaining, administering, training and managing quality systems documents that can be used effectively
- Building an internal training program to ensure quality awareness and regulatory compliance knowledge across the company
Qualifications Include:
- Bachelor's degree with a focus in life sciences/engineering or related discipline
- 8+ years of experience in RA and QA within the medical device industry
- Experience developing, improving and maintaining FDA and ISO compliant quality management systems
- Experience leading, designing, writing, submission of regulatory filings and correspondence and/or approvals
- Expert knowledge in advanced RA/QA systems, including the establishment of relevant RA/QA metrics
- Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused
