Quality Assurance Regulatory Affairs Manager

TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.

Job Summary:

The RAQA (Regulatory Affairs and Quality Assurance) Manager at TeDan Surgical Innovations (TSI) plays a crucial role in maintaining the company’s Quality System across various regulatory frameworks, such as FDA (U.S.) and EU MDR (European Union Medical Device Regulation). This role involves ensuring that the company’s processes comply with the respective requirements in each region while also helping navigate the complex regulatory landscapes for market entry. The RAQA Manager will need a deep understanding of medical device regulations and a collaborative, solution-focused approach to effectively manage regulatory requirements and quality assurance tasks within a highly dynamic and cross-functional environment.

Key Responsibilities:

• Quality System Management: Ensure the continued maintenance and improvement of TSI's Quality System to meet compliance standards for multiple regulatory bodies, including FDA, MDSAP, EU MDR, and others as applicable.
• Cross-functional Collaboration: Work closely with various teams, including Research and Development (R&D), manufacturing, and senior leadership, to streamline processes that support both new market entry and ongoing product compliance.
• Regulatory Strategy: Help to develop and execute strategies for regulatory submissions, approvals, and compliance. This includes preparing documentation for product certifications, approvals, and market access.
• Team Management: Lead and manage a team of RAQA professionals, ensuring their alignment with organizational goals and regulatory needs. This includes training, mentoring, project management and performance reviews.
• Project Oversight: Oversee cross-departmental projects related to regulatory and quality assurance activities, ensuring efficient project execution and timely achievement of milestones.
• Compliance Audits and Inspections: Prepare for and facilitate regulatory audits and inspections, ensuring that TSI maintains a state of inspection readiness.

Education & Experience:

• Bachelor's of Science in Biomedical, Mechanical, Industrial Engineering, or related field.
• 7-10 years in medical device QMS roles, with proven experience in managing multiple projects and teams.

Skills & Expertise:

• Proficient in FDA QSR, ISO standards, MDSAP, EU MDR or similar compliance schemes; experienced in regulatory audits and inspections.
• Strong communication skills, with the ability to define key issues and develop action plans independently.
• Proficient with office equipment and software applications. Inclusive but not limited to eQMS platforms.

Leadership & Business Acumen:

• Leadership experience in managing teams and projects with a focus on trust, accountability, and teamwork.
• Basic business understanding of the financial impact of projects and regulatory decisions.

This role requires a strong mix of technical, communication, leadership, and business skills to effectively manage regulatory and quality assurance processes.

Physical Requirements:

• Business casual attire.
• Requires attending corporate functions.
• Occasionally may require travel (5-10%).