Regulatory Affairs Specialist (m/w/d) Risk Management & Post Market Surveillance

We are offering a position in the medical device sector with ambitious and passionate people building meaningful products for patients all over the world. Our work environment is agile and allowing for collaboration with smart people and knowledge sharing in cross functional teams. As a fast-growing organization, we provide ample room for development and our remote work policy allows for more flexibility for our employees.

About the position

The Regulatory Affairs Specialist ensures the compliance of the risk management and post market surveillance process according to the regulations and our quality management system and interacts with the international risk and post market team as well as the R&D team and Clinical Research. The Regulatory Affairs Specialist maintains, reviews, and approves risk management and post market surveillance documentation and coordinates technical experts, deploying best practice in risk management and post market surveillance, standard operating procedures and general guidance. In this role, you will disseminate knowledge and awareness of risk management and post market surveillance within the Occlutech organization, support, among others, customer complaints, CAPA.

Aufgaben

Your work will focus on

• Working with the R&D team to support closing complaints in a timely manner
• High quality and traceable documentation on Adverse Event, CAPA and Complaint Proceeding
• Collecting, trending and escalating data related to Post Market Surveillance
• Preparing and presenting Post Market Surveillance Reports to the Management
• Generating, maintaining and completing the Post Market documentation (Periodic safety update report, PMS report & Plan) subject to review by regulatory agencies
• Assessing risk for Products and creating updating riskmanagement files in close collaboration with other departments and change management teams
• Supporting life cycle management esp. during post-market life cycle phase in collaboration with complaints department and medical device safety officer
• Keeping risk management files in alignment with EU MDR, ISO and further applicable regulations
• Conducting risk assessments for Occlutech GmbH products and globally in post market lifecycle phase and providing risk reviews

Qualifikation

We are looking for a candidate, who

• Has a university degree (min. Bachelor) preferably Master’s degree in life science or engineering or natural sciences
• Has at least 3 years of professional experience in post-market surveillance and/or risk management in the medical device industry
• Has knowledge of and practical experience QMS (ISO13485:2016/MDSAP/U.S. FDA QSR) and MDD / EU-MDR
• Communicates well in German and English
• Is able to work independently, adapt to changing tasks in a fast and dynamic work environment and manage multiple tasks
• Has good organizational, interpersonal and problem-solving skills and is able to collaborate with cross-functional teams
• Is proficient in Microsoft Office applications

Benefits

Our benefits

• A secure job in the medical device industry in a family-friendly working environment
• An interesting work scope in a growing international company
• Comprehensive onboarding and training plan in the first 6 months
• Company wide Mentoring program
• 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
• Easy access to the office on the Beutenberg Campus with an attached canteen
• Healthy work culture with a fruit basket, tea, water and coffee as well as regular team sporting events

Ready to apply?

We look forward to receiving your application (cover letter and CV).

Contact

Kristin Spanka | People & Culture Business Partner

Telephone +49 3641 508 385

Occlutech GmbH Winzerlaer Strasse 2- 07745 Jena

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Zuletzt aktualisiert am 19.04.2024