Regulatory Affairs Specialist (m/f/d) - Medical Devices (Full-time)

Gynemed GmbH & Co. KG; Schashagen; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical device company in Schleswig-Holstein is seeking a Regulatory Affairs Specialist to drive global regulatory strategies. The role involves managing compliance, preparing submissions, and collaborating with quality management. Candidates should have a relevant university degree and experience in international markets. Fluency in German and English is required. The position offers flexible working arrangements and attractive benefits.

Leistungen

Attractive benefits

Flexible remote work options

Generous flextime arrangements

Qualifikationen

• Experience in international regulatory approval procedures for medical devices.
• Knowledge of applicable standards (MDR/IVDR, EN ISO 13485, ISO 14971).
• Ability to work independently and collaboratively.

Aufgaben

• Lead cross‑functional regulatory and quality management projects.
• Prepare submissions for international agencies.
• Maintain communication with global regulatory authorities.

Kenntnisse

Regulatory requirements interpretation

Quality management systems

Cross-functional project leadership

Fluency in German

Fluency in English

MS Office proficiency

Ausbildung

University degree in medical technology or related field

Jobbeschreibung

Regulatory Affairs Specialist (m/f/d) – Medical Devices (Full-time)

We are seeking an experienced and proactive Regulatory Affairs Specialist to join our international team and strengthen our global regulatory and quality management activities. In this role, you will be responsible for driving regulatory strategies and submissions not only in Europe (MDR) and the U.S. (FDA), but also across diverse international markets. By ensuring compliance with global requirements and aligning closely with our quality management system, you will directly contribute to Nexpring’s mission to advance fertility care by ensuring our products meet the highest quality standards and global regulatory requirements. The position is based at our German subsidiary near Lübeck.

Your tasks

• Lead and support cross‑functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.
• Independently prepare submissions and change notifications for competent authorities and international agencies.
• Update, and maintain technical documentation and dossiers for medical devices (Class I to III).
• Collaborate with quality management in risk assessments, usability analyses, and post‑market surveillance.
• Maintain effective communication with global regulatory authorities, international partners, and internal teams.

Your Qualifications

• University degree in medical technology, natural sciences, quality engineering, or equivalent training with solid professional experience.
• Proven expertise in international regulatory approval procedures for medical devices (e.g., Latin America, Middle East, Asia‑Pacific, Canada, or other markets).
• Strong of quality management systems and applicable standards (MDR/IVDR, EN ISO 13485, ISO 14971).
• Conceptual and analytical thinking with the ability to apply regulatory frameworks across diverse geographies.
• Independent, structured, and detail‑oriented way of working combined with a collaborative mindset.
• Fluency in German and English; additional languages are an advantage for international registrations.
• Confident communicator with the ability to build strong internal and external relationships.
• Proficiency in MS Office applications.

We offer

• An exciting and varied role in a collaborative, international environment.
• Direct involvement in global registration strategies, with significant responsibility for markets outside the EU and U.S.
• Flat hierarchies and the opportunity to shape processes after structured onboarding.
• Attractive benefits in a growing industry.
• Modern working time models, generous flextime arrangements, and flexible remote work options after onboarding.

We look forward to receiving your detailed application documents at [e-mail]

GYNEMED GmbH & Co. KG
Wagrienring 24b
23730 Sierksdorf