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

• Compliance of the post-market, recall and

vigilance process according to the regulations

• Generate, maintain and complete Post Market

Surveillance Plan, Post Market Surveillance
Report / Periodic Safety Update Report
(PSUR).

• Collect, assess and monitor trends and

escalate compiled data during the post-market
life cycle phase. Initiate activities, if
necessary, as mentioned in section “specific
tasks and responsibilities.”

• Prepare and share Post Market documentation

subject to review by regulatory agencies

• Perform vigilance activities including notification to

National Competent Authorities

• Perform and support "corrective and

preventive actions" and "change requests".

• Interact, among others, with Risk

Management department and Complaint
Management department, Clinical department.

• Provide required deliverables related to Post

Market Surveillance & Vigilance matters.

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 Bachelor’s or Master degree in life science

or engineering degree (or related field)

• Has professional experience in post-market

surveillance field and medical device reporting

• Possesses proficient experience within OMS

(IS013485:2016/MDSAP/U.S. FDA QSR) and MOD
/ MOR

• Displays advance 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.com