Senior Regulatory Affairs Manager (m/f/d)

Olympus Corporation; Hamburg; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

30 days annual leave

Up to 40% mobile work

Holiday and Christmas bonuses

Company pension scheme

Corporate discounts for employees

Company restaurant with live cooking

Employee Assistance Program

Deutschlandticket subsidy

Free parking & bike/car leasing

Inhouse company gym

Job summary

Olympus Hamburg is seeking an experienced Regulatory Affairs professional to coordinate integrated regulatory strategies for the GI portfolio on a fixed-term contract through February 29, 2028.

You will align regulatory approaches across product groups, lead global RA initiatives, and mentor RA Managers while collaborating with R&D, manufacturing, and QA in a fast-paced, cross-cultural, international environment.

Qualifications

• Several years of Regulatory Affairs experience within the medical device industry (minimum 5 years).
• Expertise in global medical device regulatory frameworks, standards, and requirements.
• Experience with FDA and Notified Bodies.
• Experience leading regulatory projects and decision-making activities.
• Knowledge of QMS and License & Registration processes.
• Experience collaborating with R&D, Manufacturing, and other functions in agile environments.
• Strong written and verbal English communication skills.
• Intercultural experience in global environments (Europe, Japan, US).

Responsibilities

• Coordinate and facilitate development of integrated regulatory strategies across the GI portfolio.
• Harmonize regulatory approaches across product groups and Regulatory Affairs teams.
• Assess global regulatory requirements and translate into strategic recommendations.
• Align cross-functional stakeholders on regulatory topics and decisions.
• Identify regulatory synergies and opportunities for process improvement.
• Support governance, maintenance, and improvement of QMS processes.
• Contribute to global RA standards and process excellence initiatives.
• Facilitate collaboration and knowledge sharing across global RA teams.
• Communicate regulatory strategies and developments to stakeholders.
• Mentor Regulatory Affairs Managers (no direct reports).

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory project management

English communication

Intercultural competence

Mentoring

Education

Bachelor's degree in Engineering/ Life Sciences/ Medical Technology

Master's degree preferred

Job description

Your Responsibilities We are offering this position as a fixed-term contract until 29 February 2028.

• Coordinate and facilitate the development of integrated regulatory strategies across the GI portfolio
• Alignment and harmonization of regulatory approaches across product groups and Regulatory Affairs teams
• Assessment of global regulatory requirements and translation into strategic recommendations
• Cross-functional stakeholder alignment on regulatory topics and decision-making
• Identification of regulatory synergies and process efficiency opportunities
• Support the governance, maintenance, and continuous improvement of the global License & Registration QMS processes
• Contribution to global RA standards, requirements, and process excellence initiatives
• Facilitation of collaboration, transparency, and knowledge sharing across global RA teams
• Communication of regulatory strategies and key regulatory developments to stakeholders
• Mentoring and professional support of Regulatory Affairs Managers (no direct reports)

Your qualification - Bachelor's degree in Engineering, Life Sciences, Medical Technology, or a related field; Master's degree preferred

• Several years of Regulatory Affairs experience within the medical device industry (minimum 5 years)
• Expertise in global medical device regulatory frameworks, standards, and requirements
• Experience with international regulatory authorities and organizations, including FDA and Notified Bodies
• Experience leading complex regulatory projects and regulatory decision-making activities
• Knowledge of Quality Management Systems (QMS), including License & Registration processes
• Experience collaborating with product development teams in agile and fast-paced environments
• Strong interpersonal skills with the ability to manage effective cross-functional working relationships (R&D, Manufacturing, Supply Chain, Quality, etc.)
• Ability to translate regulatory requirements into business-focused recommendations and align diverse stakeholders
• Excellent written and verbal communication skills in English
• Intercultural competence with experience working in global environments, ideally across Europe, Japan, and the US
• Strong influencing, relationship-building, mentoring, and continuous improvement mindset

Your benefits - 30 days of annual leave

• Up to 40% 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 inhouse company gym

About Olympus At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

For more information, visit

www.olympus-europa.com

and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA.

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.