Director Of Quality & Regulatory - North America

Thuasne USA and Knit-Rite are well established manufacturers of medical devices for the orthopedic, prosthetic, orthotic, diabetic and medical compression markets both in the US and worldwide. As divisions of the Thuasne Group of France, a 175-year-old family-owned business, we produce products daily that help improve the quality of people's lives all over the world. Watch this video to learn more about Thuasne, their rich history and the depth of products produced and sold daily around the world!
We operate multiple subsidiaries across North America and are currently seeking a highly experienced Director of Quality & Regulatory to lead the integration of Quality systems and ISO 13485 certifications across these entities. This position will be based in Kansas City, KS.
What You'll Get To Do
The Director of Quality & Regulatory - North America will play a critical role in ensuring that our company maintains the highest standards of Quality, compliance, and regulatory adherence across all subsidiaries in North America. This position requires a strong leader with extensive experience in medical device quality management and regulatory affairs. This position will be a member of the North America Management Team.
The Essentials

• Manage the Quality team in the execution of all aspects of the QMS including but not limited to: NCRs, CAPAs, Internal Audits, Supplier Control, External Audits, Risk Management, Process Validations, Design Control and daily management of all Quality Assurance functions.
• Lead the integration of Quality management systems across multiple subsidiaries to ensure consistency, efficiency, and compliance with ISO 13485 standards and FDA 21 CFR 820, including applicable international regulations as required.
• Develop and execute a comprehensive integration plan, including the harmonization of policies, procedures, and processes.
• Stay abreast of FDA regulations, standards, and guidelines relevant to medical devices and ensure that all subsidiaries are in full compliance.
• Collaborate with regulatory agencies, notified bodies, and auditors during inspections and audits.
• Oversee the maintenance and attainment of ISO 13485 certifications for all North American subsidiaries.
• Oversee the processes outlined in the QOPs, and the maintenance, review, changing, and approvals of all upper-level documents (QOP's), including monitoring and evaluating the Document Control process for all stakeholders.
• Manage the Quality team in the execution of all aspects of the QMS including but not limited to: NCRs, CAPAs, Internal Audits, Supplier Control, External Audits, Risk Management, Process Validations, and Design Control, as required
• Manage the relationship and requirements with the EU registrar, moving towards a combined registrar as part of the integration.
• Oversee the CE marking process for products intended for sale in the European Union (EU).
• Ensure compliance with EU Medical Device Regulation (MDR) requirements.
• Establish and enforce quality assurance and control programs to ensure the highest product quality and safety standards.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
• Collaborate closely with cross-functional teams, including R&D, Operations, and Sales, to ensure seamless product development, production, and market entry.
• Act as a subject matter expert and provide guidance on regulatory requirements and quality best practices.
• Oversee the preparation and submission of regulatory documentation, including 510(k) submissions and Technical Files.
• Generate and present quality and regulatory reports to executive leadership and stakeholders.
• All other duties as assigned or required

What You'll Bring

• Bachelor's degree in a related field required (advanced degree preferred).
• A minimum of 10 years of progressive experience in quality and regulatory management within the medical device industry.
• Strong knowledge of FDA and cGMP regulations, ISO 13485 standards, and international regulatory requirements.
• Proven track record of successfully leading integration efforts of a quality and regulatory organization in a multi-subsidiary environment.
• Excellent leadership, written and oral communication, interpersonal skills and the ability to work effectively acrossdepartments & organizations.
• Strong leadership and management skills, with a steadfast resolve and personal integrity are required: ability to provide direction, facilitation, support, reinforcement and coaching to individuals and teams.
• Ability to travel as needed to various subsidiary locations within North America including the United States and Mexico (approx. 1 week per month) Estimated travel 20-25%
• Must maintain a valid US Driver's License and passport
• Proven ability to provide direction, facilitation, support, reinforcement and coaching to individuals and teams
• Ability to multi-task and establish priorities in a fast-paced environment with minimal direction or intervention.

What We Offer

• Competitive Compensation package
• Excellent Bonus Opportunity
• Competitive Benefits that include medical, dental, & vision insurances
• 401K with company match
• Convenient Metro Location
• Family Atmosphere
• Paid Time Off
• Career Development Opportunities

If you are detailed, driven, and passionate about helping make a difference, this is the job for you!
Equal Opportunity Employer: Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran's status, age or disability.
Drug-free work environment
Thuasne USA/Knit-Rite, LLC and affiliates participate in E-Verify
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