Associate Director, DACH

Jobtailor; GVV March-Umkirch; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a seasoned Regulatory Affairs leader to drive strategy and compliance across Germany, Austria and Switzerland for DePuy Synthes products. You will oversee regulatory portfolio development, ensure EU MDR alignment, and enable timely market access in the DACH region.

You will partner with Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs to shape regional policy, lead regulatory inspections, and guide lifecycle management across multiple markets.

Qualifikationen

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related field.
• Advanced degree or professional certification in Regulatory Affairs preferred.
• Typically 8–10 years of progressive Regulatory Affairs experience in medical device or healthcare industries.
• Strong knowledge of EU MDR and regulatory requirements across DACH (Germany, Austria, Switzerland).
• Experience leading multi-country regulatory portfolios and strategy execution.

Aufgaben

• Provide regulatory leadership across Germany, Austria, and Switzerland for market access.
• Lead regulatory strategy and execution across DACH in line with global objectives.
• Ensure compliance with EU/ country requirements and quality systems.
• Support product registrations, renewals, variations, and lifecycle management.
• Serve as senior escalation point within International QARA for DACH Local Markets.
• Partner with Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs.
• Monitor regulatory changes and assess impact on products and operations.
• Support inspections, audits, and health authority interactions.
• Lead and develop regulatory talent, fostering compliance and performance.
• Shape regional policy initiatives critical to business strategy and growth.

Kenntnisse

Regulatory leadership

EU MDR expertise

Regulatory strategy

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Regulatory Affairs or Life Sciences

Advanced degree in Regulatory Affairs (preferred)

Tools

eCTD experience

Jobbeschreibung

Responsibilities

• Provide regulatory leadership across Germany, Austria, and Switzerland, ensuring compliance with local and regional regulatory requirements while enabling timely and sustainable market access for DePuy Synthes products
• Lead and oversee regulatory affairs strategy and execution across DACH local markets in alignment with global regulatory objectives
• Ensure compliance with country‑specific and EU regulatory requirements, internal policies, and quality system standards
• Provide strategic regulatory guidance to support product registrations, renewals, variations, and lifecycle management
• Serve as the senior regulatory escalation point for DACH Local Market Support within the International QARA organization
• Partner with cross‑functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs
• Monitor regulatory changes across DACH markets and assess potential impacts to products, portfolios, and operations
• Support regulatory inspections, audits, and health authority interactions as required
• Lead, coach, and develop regulatory talent, fostering strong compliance, accountability, and performance
• Ensure proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required)
• Advanced degree or professional certification in Regulatory Affairs (preferred)
• Typically 8–10 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or other regulated industries
• Strong knowledge of EU MDR and regulatory requirements across Germany, Austria, and Switzerland
• Demonstrated experience leading multi‑country or regional regulatory portfolios
• Proven ability to develop and execute regulatory strategies aligned to business objectives
• Ability to operate effectively in a global, matrixed organization
• Experience supporting global or regional regulatory operating models (preferred)
• Experience working in multinational medical device or healthcare organizations (preferred)
• Exposure to regulatory inspections, audits, and authority negotiations (preferred)
• Demonstrated success driving regulatory transformation or process improvement initiatives (preferred)
• Regulatory Affairs Certification (RAC) or equivalent (preferred)
• Strong leadership, stakeholder management, and decision‑making skills