Director, Regulatory Affairs (f/m/d)

eResearchTechnology GmbH; Estenfeld (VGem); Vor Ort; EUR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Hybrid work model (1–2 days remote)

Professional development & training

Well-being programs

Zusammenfassung

Clario, part of Thermo Fisher Scientific, is seeking a Director of Regulatory Affairs to lead global regulatory strategy across the full product lifecycle, ensuring FDA, ISO, MDR compliance and patient safety.

You will mentor hardware and software teams, collaborate with PM, QA, and supply chain, and drive submissions such as FDA 510(k) filings and international registrations in a hybrid work environment.

Qualifikationen

• Master’s degree in Engineering, Life Sciences, or a related technical field.
• 6+ years of experience in the medical device industry.
• 4+ years of Regulatory Affairs within medical devices or pharmaceutical products.
• 3+ years of proven leadership experience managing or guiding teams.

Aufgaben

• Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical and non‑medical device regulations
• Define and implement regulatory strategies across the full product lifecycle, from development to post‑market
• Partner with Product Management, Logistics, and Engineering teams to ensure compliant product development and global market access
• Establish and optimize global processes for trade compliance, import/export, and supply‑chain regulatory requirements
• Guide and mentor a team of hardware and software development engineers, providing regulatory expertise across projects
• Assess regulatory impact of changes to design, materials, labeling, software, and suppliers
• Support regulatory submissions, including FDA 510(k) filings and international product registrations
• Review and approve product labeling, technical documentation, and marketing materials to ensure regulatory alignment
• Participate in internal, external, and vendor audits and contribute to corrective and preventive action initiatives
• Act as Person Responsible for Regulatory Compliance (PRRC) under MDR requirements
• Oversee the development and maintenance of SOPs and work instructions aligned with global standards
• Support post‑market surveillance, vigilance reporting, and continuous improvement activities

Kenntnisse

Regulatory leadership

Regulatory affairs

FDA regulations

ISO standards

GxP & MDR

Cross-functional leadership

Regulatory submissions

Audits & inspections

Ausbildung

Master’s degree in Engineering, Life Sciences, or related field

Jobbeschreibung

Overview

Join Clario, part of Thermo Fisher Scientific, as Director, Regulatory Affairs (f/m/d) and play a critical role in ensuring that innovative clinical trial technologies meet global regulatory standards – helping bring life‑changing therapies to patients faster. In this role, you will shape regulatory strategy, guide cross‑functional teams, and ensure compliance across global markets, making a meaningful impact on patient safety and product quality.

What We Offer

• Competitive compensation
• Flexible working hours and working time accounts to support work‑life balance
• Hybrid work model, allowing 1-2 days of remote work per week
• Support for professional development through internal and external training and certification programs
• Attractive benefits – security, flexibility, support, and well‑being
• Engaging employee programs

Responsibilities

• Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical and non‑medical device regulations
• Define and implement regulatory strategies across the full product lifecycle, from development to post‑market
• Partner with Product Management, Logistics, and Engineering teams to ensure compliant product development and global market access
• Establish and optimize global processes for trade compliance, import/export, and supply‑chain regulatory requirements
• Guide and mentor a team of hardware and software development engineers, providing regulatory expertise across projects such as respiratory, imaging, and cardiac safety solutions
• Assess regulatory impact of changes to design, materials, labeling, software, and suppliers
• Support regulatory submissions, including FDA 510(k) filings and international product registrations
• Review and approve product labeling, technical documentation, and marketing materials to ensure regulatory alignment
• Participate in internal, external, and vendor audits and contribute to corrective and preventive action initiatives
• Act as Person Responsible for Regulatory Compliance (PRRC) under MDR requirements
• Oversee the development and maintenance of SOPs and work instructions aligned with global standards
• Support post‑market surveillance, vigilance reporting, and continuous improvement activities

Qualifications & Experience

• Master’s degree in Engineering, Life Sciences, or a related technical field
• 6+ years of experience in the medical device industry
• 4+ years of experience in Regulatory Affairs within medical devices or pharmaceutical products
• 3+ years of proven leadership experience managing or guiding teams
• Strong knowledge of FDA regulations, ISO standards, and global medical device requirements (including 510(k) submissions and MDR)
• Experience interacting with regulatory authorities and supporting audits and inspections
• Understanding of clinical trial environments and GCP is highly desirable
• Excellent analytical, organizational, and communication skills
• Fluency in English and German
• Detail‑oriented with strong problem‑solving capabilities and the ability to manage complex regulatory challenges