Senior Manager Health Hazard Assessments (m/f/d)

OLYMPUS EUROPA SE & CO. KG; Hamburg; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading global medical technology company seeks a Senior Health Hazard Assessment Manager. In this role, you will lead a team of engineers to ensure compliance with safety regulations, manage health hazard assessments, and drive risk management initiatives globally. This position requires strong leadership skills and extensive experience in the medical device industry.

Leistungen

30 days of annual leave

Flexible working options with overtime compensation

Holiday and Christmas bonuses

Comprehensive pension scheme

Subsidized company restaurant

Employee Assistance Program

Transportation subsidies

Access to in-house gym

Qualifikationen

• Minimum 10 years in medical devices or regulated industry focusing on risk management.
• At least 5 years managing teams with performance oversight.
• In-depth knowledge of FDA regulations and ISO standards.

Aufgaben

• Manage and supervise a global team of HHA Senior and Principal Engineers.
• Ensure timely completion of Health Hazard Assessments (HHAs).
• Provide expertise in post-market risk management.

Kenntnisse

Communication skills

Collaboration skills

Problem-solving skills

Ausbildung

Bachelor’s Degree in a technical or science-related field

Jobbeschreibung

Senior Manager Health Hazard Assessments (m/f/d)

Join Our Team as an Senior Health Hazard Assessment Manager!

Take the lead in a dynamic, global role where you'll manage a team of engineers to ensure the timely and thorough completion of Health Hazard Assessments (HHAs) across Olympus. Collaborate with cross-functional teams worldwide, provide expert post-market risk management, and step in as a delegate for the HHA Chair when needed. Play a key role in upholding Olympus’ commitment to safety and regulatory compliance. If you're ready to make an impact on a global scale, this is the opportunity for you!

The position is preferably based in EMEA HQ in Hamburg, but it can also be located in other Olympus locations such as Coimbra, Portugal; Southend-on-Sea, UK; or Přerov, Czech Republic, if needed.

Your Responsibilities

1. Manage and supervise a global team of 2-4 HHA Senior and Principal Engineers, ensuring the successful completion of HHAs.
2. Oversee recruitment, training, and performance management of HHA engineers to meet team and organizational goals.
3. Collaborate with cross-functional teams such as quality, regulatory, and engineering to track and ensure the timely completion of HHAs.
4. Ensure HHA target completion dates are met, proactively addressing any delays or issues.
5. Contribute to process documentation, including procedures, work instructions, and templates, to improve the HHA process.
6. Act as a delegate for the HHA Chair, stepping in for decision-making and team discussions as needed.
7. Provide post-market risk management expertise to support the HHA team in evaluating and mitigating product risks.
8. Lead and facilitate corrective actions (CAPAs) and non-conformance (NC) reports as necessary to resolve issues within the HHA process.

Your Qualifications

• Bachelor’s Degree in a technical or science-related field.
• At least 10 years of experience in the medical device or regulated industry, focusing on risk management, HHAs, or corrective actions.
• Minimum of 5 years of experience in managing teams, including overseeing performance and workload.
• In-depth knowledge of FDA QSRs, ISO 13485, ISO 14971, and 21 CFR 820 regulations.
• Proven ability to manage multiple projects simultaneously and meet deadlines.
• Strong communication skills, both verbal and written, with the ability to facilitate meetings and presentations.
• Excellent collaboration skills across teams and cultures.
• Self-motivated with problem-solving skills and a sense of urgency.

Your Benefits

Our Benefits vary depending on the EMEA location: You’ll enjoy generous leave, flexible working options, bonuses, employee discounts, pension and financial benefits, health and well-being support, commuting benefits, and sports and fitness opportunities.

For the Hamburg location, we offer:

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

About Olympus

At Olympus, our purpose is to make people’s lives healthier, safer, and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions for early detection, diagnosis, and minimally invasive treatments, aiming to improve patient outcomes and elevate the standard of care.

With over 100 years of history, Olympus is committed to societal contribution through innovative products designed to deliver optimal outcomes worldwide.

For more information, visit www.olympus-europa.com and follow us on LinkedIn: linkedin.com/company/OlympusMedEMEA.

Additional Information

We value diverse perspectives and lifestyles and encourage applications from all individuals regardless of gender, nationality, ethnicity, religion, age, sexual orientation, or identity.