Regulatory and Quality Assurance Specialist

ROLE SUMMARY

The Regulatory Affairs and Quality Assurance (RA/QA) Specialist is a hands-on individual that will lead and assist the day-to-day operational activities of the department and ensure that the project/s, department milestones and goals are met. This position is based at Noctrix Health’s headquarters in Pleasanton, CA but is intermittently remote until our offices are open.

SPECIFIC RESPONSIBILITIES

• Work closely with the RA/QA team and key stakeholders to implement and execute to the quality/regulatory processes for products requiring governmental approval and handling all domestic and international government requirements.  Specifically, provide day to day support in implementation and improvement of Noctrix’s QMS and Regulatory process.
• Assist in compilation, preparation and review of the domestic and international regulatory submissions, registrations and product updates.
• Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies.
• Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes. Organizes and maintains RA files
• Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.
• For new, routine or ongoing issues, help prepare for communication with regulatory agencies.
• Provides inputs in preparations for meetings with regulatory agencies and investigators.
• Support in obtaining regulatory approvals and certifications for the company as and when necessary; 510(k)’s, ISO 9001, ISO 13485, QSR, CE and foreign government regulatory approvals.
• Support and facilitate external inspections, audits and investigations; FDA (Fed and State), MDSAP, ANVISA, etc., as well as Notifying Bodies, to ensure regulatory compliance.
• Assist internal audit related activities annually and whenever necessary to ensure continued regulatory compliance.
• Support in coordination of the inspection of the organization and contract facilities to ensure regulatory compliance.
• Process complaints and maintain necessary documentation for USFDA, EU-MDR, and regulatory reporting.
• Support in generation and maintenance of all DHF’s, Technical Files/documentation, including risk management, design reviews and formal product transfer as needed.
• Support R&D efforts and product transfer to manufacturing/contract manufacturing.
• Able to work cross-functionally with other departments
• Improve existing processes by streamlining and automating processes where necessary.
• Provide leadership to assure that products meet quantity, cost, quality and regulatory objectives.
• Monitors, researches and obtains information on FDA clearances/approvals of competitors, and proactively shares this information.
• Mentor junior RA/QA staff as needed/assigned
• Perform other assigned duties as needed.

 

REQUIREMENTS, EXPERIENCE

• A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
• A minimum of 5 years of experience in an FDA regulated industry required; with medical devices.
• A minimum of 3 years of Medical Device Quality/Regulatory Affairs experience required.
• Previous experience with regulatory submissions required.
• ISO 13485:2016 Audit and Certification process experience
• Direct experience with 510(k)’s, De Novo, CE (EU MDR/MDD), Regulatory Processes and submissions
• Must have a working understanding and knowledge of both U.S. and international regulations, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485 Medical devices — Quality Management Systems, EU MDR and all relevant domestic and international standards
• Experience compiling technical files/documentation
• Experience with Facility and Product Registrations
• Working knowledge of IEC/ISO standards such as, 60601, 14971, 62304, 62366

 

NICE TO HAVE

• Thorough understanding of product development process and design control.
• General understanding of regulations applicable to the conduct of clinical trials.
• Thorough understanding of FDA and international medical device regulations.
• Previous experience with Class II medical devices preferred.
• Experience interacting with regulatory agencies preferred.
• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
• Ability to analyze and resolve non-routine regulatory issues using independent judgment.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
• Excellent analytical and writing skills.
• Excellent interpersonal, written and oral communication skills. • Effective organizational skills.

 

BENEFITS

• Competitive salary & bonus
• Equity in a high-growth startup backed by top-tier VCs
• Medical, vision and dental benefits
• Retirement plan support
• Flexible on-site/remote work options

CONTACT: info@noctrixhealth.com