Vice President Global Quality Assurance and Regulatory Affairs

Standort: Radolfzell, DEU

Stellenbeschreibung:

TASKS

As NDI’s Vice President, Global Quality Assurance & Regulatory Affairs, you will shape the quality and regulatory strategy for our global operations and medical and non-medical product portfolio. In this new role, you will bring teams and sites together, strengthen our Quality Management System, and guide regulatory strategies that enable product development, market access, and sustainable growth.

Reporting to the President, you will bring an independent quality and regulatory perspective to executive decisions, helping protect product reliability, customer confidence, and patient safety. You will develop functional and site leaders, establish clear decision-making authority and accountability, and build the capabilities needed for long-term success.

• Set and execute NDI’s global quality and regulatory strategy, translating business priorities into annual plans, measurable objectives, budgets, and resource investments.
• Lead the global QA/RA organization, defining its structure and resource priorities, developing functional and site leaders, and strengthening delegation and leadership succession.
• Foster a culture of quality across the organization, partnering with leaders to embed clear ownership of quality and compliance into everyday decisions and operations.
• Lead global Quality Management System governance and performance, simplifying and aligning practices across sites while holding leaders accountable for applicable ISO 14971, ISO 13485, regulatory, and customer requirements.
• Shape global regulatory strategy and market access priorities for new and existing products, overseeing submissions, registrations, and lifecycle compliance within NDI’s scope of responsibility.
• Develop a strong understanding of NDI’s spatial measurement technologies, customer applications, and supply chain to guide cross-functional quality and regulatory decisions.
• Provide executive oversight of design, software, and manufacturing process quality, ensuring appropriate design controls, verification, validation, and risk management throughout the product lifecycle.
• Oversee supplier and contract manufacturer quality, product acceptance and release, nonconformances, and corrective and preventive action (CAPA).
• Drive measurable improvements in product and process quality through data analysis, effective root-cause investigation, and prevention of recurring issues.
• Establish oversight of complaints, post-market monitoring, safety assessments, reporting, and field actions, ensuring timely investigation, escalation, and resolution by accountable leaders.
• Provide executive oversight of regulatory inspection and audit readiness, ensuring leaders deliver effective preparation, responses, and sustained corrective action.
• Represent NDI in significant regulatory matters and strategic customer and supplier discussions, while empowering functional leaders to manage routine interactions.
• Set global performance measures and management review expectations, evaluate results with leaders, and advise the President and executive team on risks, investment needs, and improvement priorities.
• Anticipate the business impact of evolving regulations and standards, setting priorities and sponsoring implementation programs that support compliance and business continuity.
• Establish clear escalation pathways and decision-making authority, exercising independent judgment on significant quality risks and authorizing or recommending action within delegated authority.

PROFILE

• Bachelor’s degree in engineering, life sciences, or a related technical discipline; an advanced degree or relevant quality or regulatory certification is an asset.
• 15+ years of progressive medical device QA and/or regulatory affairs experience, with substantial responsibility across both functions.
• 7+ years of senior leadership experience, leading managers or functional leaders across multiple sites or international markets.
• Experience setting global regulatory strategy and leading quality systems in regulated medical device manufacturing, translating requirements into practical systems that maintain compliance, enable market access, and protect product quality and patient safety.
• In-depth knowledge of ISO 13485, ISO 14971 and medical device risk management; FDA requirements, including QMSR (21 CFR Part 820), reporting, corrections and removals, and complaint handling; and regulatory frameworks in Canada, the EU, UK, Switzerland, Japan and South Africa, including Health Canada requirements and EU MDR, as applicable to the product portfolio.
• Experience leading regulatory inspections and audits, guiding the resolution of significant quality issues, and overseeing CAPA, supplier quality, and post-market processes.
• Experience supporting products from development through manufacturing and commercialization, including design controls, technical documentation and change management.
• Experience with electronic quality systems and data-driven improvement; experience leading a quality organization through significant growth or global process alignment is strongly preferred.
• Experience with spatial measurement, embedded hardware, software-enabled technology, OEM medical device partnerships or sterile medical device manufacturing is an asset.
• Executive judgment that balances quality, regulatory, business, customer, and patient safety priorities.
• Ability to challenge decisions constructively, communicate risk clearly, and influence senior leaders and technical teams.
• Collaborative leadership that builds trust across functions and sites, develops leaders, and enables organizational change.

Ansprechpartner:in

Annette Schönepauck - Manager Human Resources

+497732823410

Wenn Sie Teil eines offenen, engagierten und motivierten Teams werden möchten, in dem Zusammenarbeit, Innovation und gegenseitige Unterstützung großgeschrieben werden, finden Sie bei NDI ein Umfeld, in dem Sie etwas bewegen können. Bei uns arbeiten Menschen zusammen, die Verantwortung übernehmen, Wissen teilen und unterschiedliche Perspektiven als Stärke verstehen. Durch enge Zusammenarbeit über Teams hinweg schaffen wir innovative Lösungen und erzielen gemeinsame Erfolge. Dabei verbindet uns die Leidenschaft für Technologie, kontinuierliche Weiterentwicklung und der Anspruch, mit unserer Arbeit einen echten Beitrag zur Medizintechnik von morgen zu leisten. Werden Sie Teil eines Umfelds, in dem Ihre Ideen geschätzt werden, Ihre Entwicklung gefördert wird und Ihre Arbeit einen spürbaren Unterschied macht. Fühlen Sie sich angesprochen? Dann freuen wir uns auf Ihre Bewerbung.