Senior Regulatory Affairs Manager (m/w/d)

Senior Regulatory Affairs Manager (m/w/d)

Olympus Winter & Ibe GmbH (OWI) | Chief Quality Officer

Responsibilities:

• Plan and update on global regulatory strategy for product submissions
• Perform impact assessment on project roadmap and project activities
• Collaborate with cross-functional teams to develop comprehensive regulatory plans
• Monitor regulatory trends and predict potential impacts on current and future projects
• Analyze past submission outcomes to identify areas for improvement
• Develop and implement strategies to enhance the quality and efficiency of regulatory submissions
• Share best practices and lessons learned across the regulatory affairs team to foster continuous improvement globally
• Participate in relevant boards (e.g. change board or project boards) to address regulatory changes
• Conduct regulatory risk assessments and develop mitigation strategies on portfolio
• Support interpretation and implementation of new regulatory requirements and guidelines with cross-functional departments (e.g. Regulatory Operations, R&D and others)
• Support development and updating of internal processes and procedures to ensure compliance with current regulatory standards

Qualifications:

• A degree in Medical Engineering or a related field
• At least 3-5 years of experience in the respective field
• Experience in international markets
• Excellent written and verbal communication skills in English (additional language skills are an advantage)
• Ability to present complex topics clearly and persuasively
• Strong teamwork skills and the ability to work effectively with different departments and external partners
• Strong analytical skills to assess data and identify opportunities for project optimization
• Solution-oriented mindset for quick and effective problem-solving during project execution

Benefits:

• 30 days of annual leave
• Up to 60% mobile work possible + flexible work time model with overtime compensation
• Holiday and Christmas bonuses
• Corporate benefits discounts for employees
• Comprehensive company pension scheme and capital-forming benefits
• Company restaurant with live cooking and healthy food (subsidized)
• Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
• Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
• Various subsidized company sports groups and access to the in-house company gym

Further Information:

Your future inclusive workplace awaits.

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.
We warmly encourage all who wish to bring their talents to Olympus to apply.