Piper Clinical Solutions is actively seeking a Regulatory Affairs Associate to join a well-established global medical device company. This position is onsite working Monday through Friday 9-5 in RTP.
Responsibilities for Regulatory Affairs Associate:
- Help with preparation of regulatory submissions, manage regulatory documentation and licenses, and close out regulatory queries.
- Manage all documentation including design history files, SOPs, and any other documentation to ensure all is FDA, EU MDR, and ICH compliant.
- Coordinate with multiple departments including manufacturing, marketing, executive management, labeling, regulatory affairs, quality assurance and engineering.
- Work with quality management systems (QMS) including document control and change control in regards to regulatory affairs. Assist with audits, and preparation of global regulatory submissions and reports.
Technical Requirements for Regulatory Affairs Associate:
- Bachelor’s Degree in public health, chemical engineering, biology or related field.
- At least 1 years of experience working in a pharmaceutical or medical device environment.
- Experience with regulatory agencies including FDA, ICH, and EMA within quality assurance or regulatory affairs.
- Minimum 1 years of experience working in quality assurance or document control within a regulated manufacturing environment.
- Excellent written, verbal, communication, and organizational skills.
Compensation & Benefits for Regulatory Affairs Associate:
- Compensation: $22-27/hour based on previous salary history and experience
- Full Benefits: Medical, Dental, Vision, etc.
Qualified candidates please send resumes to Meg Smith at email@example.com.