Location: Onsite (Beutenberg Campus in Jena, Germany)
Work model: Full time (40 hours)
Department: Regulatory Affairs
About Occlutech
Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission
to improve the quality of life for people with heart conditions. The vision is to become a global
leading specialist provider in cardiac devices, addressing congenital heart defects, stroke
prevention, and heart failure. Occlutech has a broad and proven portfolio, based on proprietary
technology, and over 200 patents with more than 200,000 products sold. The company markets
and sells its products in over 70 countries and has around 300 employees.

Your work will focus on

• Management of process for risk assessments:

Ensure compliance of the risk management
process according to ISO 14971 and

Occlutech’s QMS

• Manage risk documents during the design

phases (Providing guidance for Preliminary
hazard analysis, preparation of risk
management plan, supporting for risk
identifications and evaluations together with
risk management team, and preparation of risk

management file)

• Plan and perform risk management activities

within the Occlutech organization

• Maintaining, reviewing and approving risk

management documentation (particular Risk
Management Plan, Risk Benefit Analysis, Device

Risk Assessment, Risk Management Report etc.)

• Coordinate the required technical experts for

risk assessment activities

• Collaboration with all departments involved is

risk management activities

• Provide risk assessment to other processes

(e.g. CAPA, change requests, complaints)

• Implement risk management best practice,

standard operating procedures and general
guidance for the application of risk
management in device development and post

market phase

• Disseminate knowledge and awareness of risk

management within the Occlutech organization

• Subject matter expert for risk management

during internal and external audits and/or
inspections

Our benefits

• A secure job in the medical

device industry in a family-

friendly working environment

• Comprehensive onboarding and

training plan in the first 6 months

• Good work-life balance through

30 days of vacation, flexible
working hours and hybrid,
family-friendly working time

models

• Employer-financed retirement

insurance

• Team building, employee, and

company events

• Healthy work culture with a fruit

basket, tea, water and coffee as
well as regular team sporting
events

We are looking for a candidate, who

• Has a scientific technical degree e.g. biomedical

engineering with profound experience in the field

(> 3 years)

• Has professional experience in the medical

device or pharmaceutical industry in the field

of risk management

• Possesses advanced knowledge in Risk

Management of Medical devices

• Uses IT Tools: Excel (advanced), Word, Power

Point

• Has accuracy, ability for logical thinking and

well-structured work organization

• Strong organizational, planning and analytical

skills, results oriented

• Excellent written and spoken English skills

Ready to apply?
We look forward to receiving your
application (cover letter and CV to
bewerbung@occlutech.com .
Only applications in English will be
evaluated.
Contact
Kristin Spanka |People & Culture Business Partner
Occlutech GmbH Winzerlaer Strasse 2- 07745 Jena
www.occlutech.co

Please refer the Job description for details