Regulatory Affairs Manager (Senior) (m/f/d)

Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.

Get to know us and join our team as

Regulatory Affairs Manager (Senior) (m/f/d)

Job Function: Patient Health & Regulatory Affairs

Responsibilities

• You will prepare and compile regulatory submission dossiers for new medical device registrations and changes to existing products, in accordance with regulations.
• Monitoring new legislations, policies, standards and guidelines that affect the assigned product portfolio will be one of your tasks.
• The collaboration with cross-functional teams to collect necessary information is a daily mission for you.
• You will conduct post-market surveillance and report adverse events/field safety corrective actions to the authorities.
• In your role you will be supporting currently marketed products, e.g., review engineering changes, product labeling and promotional materials.
• We want you to initiate and manage projects for continuous improvement and compliance with regulatory requirements.
• You will report to the manager and relevant stakeholders on key results, serious incidents, as well as potential opportunities and risks for the company.

Your Talents

• Master of Science or Master of Engineering, specializing in medical devices or a related field.
• At least 5 years of professional experience in this or a comparable position.
• Knowledge of SAP user interfaces like PLM and Easy DM, as well as familiarity with MS Project.
• Strong service and customer orientation.
• Flexibility to adapt to various situations and personalities.
• Ability to work independently.
• Fluent in written and spoken English.

Additional Benefits

• Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required.
• 30 vacation days and various special payments.
• Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more.
• Corporate benefits and bicycle leasing.
• Subsidy for private pension plan and company health management.
• Various childcare options – at the headquarters in Tuttlingen.
• Health, sports, cultural and leisure activities – offers vary depending on location.