Associate Manager Regulatory Affairs (m/w/d)

Biosensors International Group, Ltd; Hechingen; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Biosensors International Group, Ltd in Hechingen, Germany seeks an Associate Manager Regulatory Affairs for a temporary position to support regulatory submissions, keep technical documentation updated, and monitor international requirements for medical devices.

You will collaborate across development, QA and project management, ensure MDR compliance, and maintain documentation for new markets, while leveraging English language skills and a structured, precise work approach.

Qualifikationen

• Experience in regulatory affairs for medical devices, including MDR
• Strong written and spoken English skills
• Structured, accurate and responsible way of working

Aufgaben

• Assist in regulatory submissions and approvals for new markets
• Support preparation and updating of technical documentation
• Collaborate with development, QA and project management
• Monitor regulatory intelligence and communicate requirements to stakeholders
• Coordinate with internal teams and external partners on regulatory activities

Kenntnisse

Regulatory affairs

English proficiency

MDR knowledge

Quality basics

Ausbildung

Studies in medical technology or natural sciences

Jobbeschreibung

We are looking for a highly qualified and motivated Associate Manager Regulatory Affairs to join our dynamic team (temporary position to cover parental leave) in the medical device industry. In this position you will play a key role in the approval of our products in new countries, the submission and updating of all technical documentation and in the monitoring of standards.

What to expect

• Support in the creation and management of processes related to regulatory activities
• Support in the preparation of approval / technical documentation for our medical devices
• Collaboration on product approvals for medical devices and their maintenance
• Varied and cross-departmental collaboration on projects for the development of innovative medical devices on the structural heart field
• Monitoring the relevant regulatory intelligence by researching, summarizing, and evaluating regulatory requirements for medical devices as well as informing the appropriate stakeholders in the organization
• Close technical cooperation with internal departments (e.g. development department, project management, quality department) and contact with external partners

What you bring along

• Studies in the field of medical technology, natural sciences or technology
• Curiosity and passion in the field of medical technology
• Experience in the field of regulatory affairs (EU and RoW) – at least 3 years
• Knowledge of regulatory requirements for medical devices (e.g. MDR) or biological materials desirable
• Understanding the basics related to quality assurance, development, or clinical affairs of medical devices is an advantage
• Very good written and spoken English skills
• Structured, accurate and responsible way of working