Regulatory Affairs Specialist
- 47201 Lakeview Blvd, Fremont, CA 94538, USA
THINK Surgical, Inc. develops, manufactures and markets the only active robotic surgical systems for orthopedic surgery. The systems include two components: a 3D workstation for preoperative planning, and a computer assisted tool utilized for cavity and surface preparation for hip and knee replacement surgeries. The systems have been used in thousands of joint replacements worldwide
Job Summary: The Regulatory Affairs Specialist will plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. He/she will ensure regulatory compliance to all US and EU requirements, corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products. The RA Specialist will provide greater support to the group by taking on more projects of greater complexity under minimal supervision.
The Regulatory Affairs Specialist has extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulation (QSR), 21 CFR, International Organization of Standardization (ISO) 13485:2016, ISO 14971:2007, and Medical Device Directive (MDD) 93/42/EEC. The incumbent has the ability to take strategic direction and establish efficient and regulatory compliant processes throughout the organization and with strong communication skills at all levels
Travel Requirements: ≤10% Training opportunities, Regulatory Agency meetings, Distributors, Clinical Sites, Suppliers
- Assure regulatory compliance with internal procedures and external standards.
- Spearhead Unique Device Identifier (UDI) activities for companywide implementation.
- Provide regulatory support on product development teams through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
- Provide regulatory assessments for manufacturing, design changes, and validation activities
- Provide regulatory input in quality system assessments, product development, and complaint/MDR/Vigilance handling system.
- Review and approve test protocols to support regulatory submissions.
- Support the Think Quality Policy and Quality Management System.
- Provide input and reviews Design Control documentation such as: Risk Management, Design verification, design validation, shelf life studies, pre-clinical studies, and clinical studies.
- Identify guidance documents, international standards and consensus standards, and risks and assist product development teams with their interpretation.
- Review and approve product labeling, claims, training materials and advertising/promotional materials.
- Track and maintain regulatory registrations and product blocking lists to ensure valid international regulatory clearances, sales, and commerce implications.
- Perform vigilance activities
- Assist in negotiations with the FDA or other regulatory agencies.
- Maintain regulatory affairs product files to support compliance with regulatory requirements.
- Review domestic and international Marketing Advertising and Promotional materials to ensure valid label claims are consistent with US and international rules and regulations.
- Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
- Develop, document, and implement a regulatory strategy plan to support product development and company goals
- Provide continual regulatory updates to the Management Team to ensure that processes needed for the quality system regulation are established, implemented and maintained.
- Establish and maintain regulatory information systems both electronically and hard copy.
- Responsible for Medical Device Directive.
- Serves as communicator with all regulatory agencies for both oral and written communications and reporting, ensuring reports are compiled, approved, and distributed to appropriate internal personnel as well as external agencies. Also manages the preparation and quality check of all regulatory submissions to regulatory agencies.
- Perform other duties as assigned.
- Awareness of international regulatory requirements and quality systems.
- 3+ years Regulatory Affairs medical device industry experience.
- 510(k) experience required, IDE, PMA - optional -(original/revision/supplements) preparation, submission and clearance/approval
- Proficient in 21 CFR 820 and the Medical Device Directive, international a plus
- Direct interaction with FDA reviewers/inspectors
- Working knowledge of ISO 13485 and CE mark requirements.
- Experience with medical device software in conformance with IEC 62304
- Working knowledge of MDR Reporting
- Team based work environment experience preferred with leadership of teams
- Strong interpersonal, written, oral, communication, organizational and planning skills
- Working knowledge of personal computer systems and desktop office applications
- Sound understanding of scientific principles
- Demonstrated experience in management of regulatory submissions activities.
- Demonstrated project management skills and experience.
- Able to work on a team.
- Ability to work under independently and minimal supervision.
- Must be able to work in a timeline-driven environment.
- 4 year degree in scientific area; RAC certification desired
- Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards.
- Attendance and Punctuality are essential function of the position
THINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow’s leading orthopedic solutions today, we would love to hear from you.
THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.