Our client is seeking a QA/RA Manager in the Northeast!
Our client is dedicated to creating surgeon-designed solutions with minimally disruptive access for the treatment of complex spinal pathology. They use state-of-the-art 3D printing to manufacture their products, allowing an acute sensitivity to patient anatomy. Our client is making quantum leaps in the spinal fusion market. The QA/RA Manager will work 20% with the Interventional Pain sister company in building QMS and 80% with the main Spine Orthopedics company in regulatory and quality.
- Serve as the Company Management Representative. Manage and oversee all aspects of the quality management the system, quality assurance activities, and regulatory activities including but not limited to:
- Establish and foster a compliant environment in alignment with applicable, current regulatory/quality regulations and requirements.
- Foster thorough knowledge of quality principles and compliance with quality policies throughout the organization through training and mentorship.
- Maintain overall responsibility for QMS including but not limited to, Quality Manual, document control, design control, complaints, NCRs, CAPAs, and training.
- Compile and conduct annual Management Review meetings
- Conduct annual Supplier Review meetings.
- Review and approve all internal and external Change Orders.
- Serve as Management Representative, representing the company in all regulatory and quality interactions with external regulators such as the US FDA,
- Develop and implements regulatory strategies for new and modified products and regulatory processes.
- Provide regulatory guidance and direction, to the organization and acts as a core team member on product development teams, and coordinates cross-functional deliverables required for regulatory submissions.
- Ensure submissions are prepared and submitted (e.g., 510(k)s) to obtain/maintain FDA regulatory approvals.
- Review and approves product labeling, advertising, and promotional materials to ensure claims and global regulations are met.
- Overall responsibility for regulatory pathway determinations and maintain documentation.
- Collaborate with product development to author Letters-to-File documentation for design changes to 510(k) cleared products or systems.
- Maintain current knowledge of the applicable regulations and standards and provides guidance to the organization.
- Ensure that FDA registries, such as GUDID, product registrations, and establishment registrations are maintained.
- Ensure that SOP’s relative to Regulatory Submissions are current and compliant with current regulations and standards.
- Train new personnel on relevant regulatory processes as required.
- Ensure compliance with applicable governmental laws, rules, regulations, and guidance documents, applicable to the United States and as applicable internationally, by completing introductory and annual training and maintaining knowledge of compliance.
- Bachelor’s degree required, Master’s degree (preferred)
- 10+ years of quality assurance & regulatory affairs experience in the medical device industry – Orthopedic implant medical devices (preferred)
- Experience leading FDA inspections and FDA communications
- Experience working with Notified Bodies and leading Notified Body audits
- Expert knowledge and interpretation of 21 CFR Part 820, ISO 13485, MDSAP, and GUDID