Regulatory Medical Writer
As a regulatory medical writer, you will play a crucial role in our Real-World Evidence Team, authoring Post Market Clinical Follow-Up (PMCF) Plans and Reports, contributing to the Clinical Evaluation, and Post-Market Surveillance documentation. In this role you will collaborate with internal and external partners to evaluate clinical data from diverse sources. By leveraging your regulatory writing skills and experience, you will directly contribute to fulfilling our post-market clinical data obligations under the Medical Device Regulation, leading to a successful maintenance of our comprehensive dental medical device portfolio on the European market.
The position is a 100% position (40hrs/week) as Regulatory Medical Writer for Post-Market Clinical Follow-Up. Your workplace will be Straumann group’s Southern European Hub located in Madrid, Spain but you will be working directly with the Real-World Evidence Team at Straumann’s Headquarters in Basel, Switzerland.
Your responsibilities:
* Evaluating clinical data from sources such as clinical investigations, device registry, literature, or congress reports
* Establishing and updating PMCF Plans and PMCF Reports for medical devices within our portfolio
* Summarizing output of PMCF activities in Clinical Evaluation Reports and Periodic Safety Update Reports
* Collaborating with other stakeholders to ensure timely delivery of key documents
* Ensure consistency and integrity of data across all deliverables
* Working in compliance with applicable regulations and guidelines
Your experience / personal profile:
* University degree (M.Sc. or higher) in a relevant discipline (life sciences, medical, biomedical engineering, or similar areas). Knowledge in the dental field is an advantage.
Minimum 2 years of professional experience in regulatory writing in a MedTech or Pharma company.
* Understanding of Post-Market Surveillance and Clinical Evaluation requirements under the EU MDR.
* Good analytical skills and able to interpret data.
* Excellent command in spoken and written English (proficient user)Structured and pragmatic working style.
* Self-motivation and accountability.
* Excellent interpersonal skills, ability to work collaboratively in a matrix organization.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type:Full Time
Alternative Locations:Spain : Madrid
TravelPercentage:0 - 10%
Requisition ID: 18104
#J-18808-Ljbffr