Description:
Our client, who manufactures life-saving blood transportation equipment, is seeking a Quality & Regulatory Specialist to join their team as they prepare for FDA submission. They are seeking a contractor who can act as a subject matter expert for QA/RA documentation.
Responsibilities:
- Ensure all documents are accurate, up-to-date, and readily accessible.
- Assist in preparing and maintaining quality records, ensuring completeness, traceability, and accuracy.
- Collaborate with cross-functional teams to identify document gaps and recommend improvements to meet regulatory and quality standards.
- Assist with preparation and review of documents to support regulatory submissions such as , PMA and CE mark (technical file).
- Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and Manufacturing to gather data and documentation for regulatory submissions.
- Contribute to and edit technical documents such as Risk Management Reports, Design History Files (DHF), Verification & Validation Reports
- Maintain compliance with FDA regulations (21 CFR Parts 820, 803, 806, and 807) and applicable international standards (e.g., ISO 13485, ISO 14971, ICH guidelines).
- Coordinate and participate in risk management activities, including risk assessments (FMEAs) and risk-benefit analyses
- Participate in other quality activities, including review and approval of change requests non-product software validation, CAPAs, supplier control, equipment IQ/OQ, registration, and calibration activities
- Professionally interacts and maintains effective and open communication with all personnel, vendors, manufacturers, and customers.
- Maintains a professional and positive manner and appearance at all times.
- Responsible to perform all duties safely and in a manner consistent with the policies and procedures.
- Responsible to report all accidents/incidents (e.g., motor vehicle, customer, employee) to the necessary personnel (e.g., Safety Officer, CEO and President).
- Adheres to all applicable department, production, and company related Operational, Safety
- Performs all duties as assigned.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field
- 3-5+ years of experience in FDA regulatory submissions, preferably in the medical device or pharmaceutical industry.
- Strong working knowledge of FDA regulations and guidance, quality management systems, ISO 13485, ISO 14971, and risk management principles (MDSAP a plus)
- Exceptional technical and regulatory writing skills, with attention to detail and clarity.
- Proficiency in creating, editing, and managing technical documents and submissions.
- Experience with electronic submission platforms (e.g., eCopy, ESG) is a plus.
- RAC certification or training in regulatory affairs and/or risk management is a plus.
- Excellent organizational skills and attention to detail
- Proven experience working with electronic document control systems like Enzyme, Trackwise, or other PLM systems.