Global Regulatory Devices Manager - Strategy & Submissions

Sandoz International GmbH

Kundl

Vor Ort

EUR 60.225 - 73.609

Vollzeit

14 Tage+

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Benefits dieser Stelle

Flexible working hours

Parental leave 14 weeks

Canteen meals

Mobility program

Company kindergarten

Learning & development

Zusammenfassung

Sandoz International GmbH seeks a Regulatory Affairs Device Manager to deliver global compliance for medical devices and drug-device combinations. You will drive regulatory strategy, manage interactions with Notified Bodies and regulators, and lead the creation of compliant technical documentation for successful registrations.

The role requires 5+ years in device regulation, MDR/UK/EU experience, and leadership in a matrix environment.

Qualifikationen

Advanced degree and deep knowledge of global device regulations.
Experience driving regulatory strategy and stakeholder interactions.
Proven ability to prepare technical files and CTD modules.
Excellent written and verbal communication in English.

Aufgaben

Lead regulatory input for device and combination products across regions.
Serve as primary contact for Notified Bodies and health authorities.
Deliver regulatory documents and manage registration submissions.
Support audits, certifications, and post-approval changes.
Coordinate with cross-functional teams to meet timelines.

Kenntnisse

Regulatory strategy

Notified Body interactions

MDR 2017/745

21 CFR 820 / 21 CFR 4

ISO 13485

Team leadership

Global registrations

English proficiency

Ausbildung

Master's degree in engineering or life sciences

Jobbeschreibung