Clinical Evaluation Specialist

Stryker

Lund, Skåne
Permanent
Heltid

1 månad sedan

Work Flexibility: HybridIn your new role as a Lead Clinical Evaluation Specialist within the Jolife team, you will be responsible for the Circulatory Business clinical evidence portfolio to support global market access. Subject Matter Expert for Clinical Evaluations, Post Market Clinical Follow-up, and Clinical data review.Opportunities & benefits that the role offers

This person will get great exposure to the LUCAS ™ Chest Compression System.
Opportunity to work on fulfilling projects with colleagues within the department, locally and internationally.
Help shape the future of the Jolife team to ensure we provide best in class products to our customers.
Work in Europe’s 6th best “Great Place to Work”.
Attractive flexibility in working arrangements.

Job SpecificsYou have Experience Thanks to your extensive research and academic experience; you have a strong interest in medical science, and you have proven experience (e.g. peer-reviewed publications) in the systematic review and analysis of scientific literature. You will have a minimum of 7 years’ experience in the medical device, pharmaceutical or life science industries and at least 2 years’ of experience in performing Clinical Evaluations of Medical Devices.You have the Right Academic Profile You have a university degree in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar). An advanced degree is strongly preferred. (PhD, MD, Masters).You are Fluent in English You possess an excellent command of written English and are trained in scientific writing. Having fluent Swedish would be an advantage.You love a Challenge A self-starter who enjoys problem solving and creating innovative solutions. You can organise and direct diverse activities in a changing environment, often under time pressure.You are a Collaborative Partner You build and leverage cross-functional relationships to bring together ideas, information, and industry analyses to develop best practices.You do the Right Thing You have a high level of integrity, responsibility, discipline, and attention to detail. You understand the importance of keeping tabs of what is always going on in your goals/projects.You are a Strategic Thinker You enjoy analyzing data or trends from multiple sources and formats and create a comprehensive scientific review, including in depth statistical analyses, risk management cross-check and descriptive analyses, following complex and rigorous methodologies.What will you do at Stryker?

Process owner and site Subject Matter Expert for Clinical Evaluations, Post Market Clinical Follow-up, Clinical data review and Unsolicited requests for off-label use.
Plan and perform literature searches and clinical data review.
Plan and perform Clinical Evaluations.
Plan and perform Post Market Clinical Follow up.
Support in creation of Product Safety Update Reports.
Establish state of the art (SoTA) reports and keep them up to date.
Responsible for library of scientific journal publications.
Review of promotional and advertising materials.
Clinical review of Complaints.
Handle unsolicited requests for off-label use.
Participate in New Product Development (NPD) and Engineering projects to develop clinical evidence strategy and literature search for product registration and marketing, including claims development.
Write clinical sections of regulatory submissions.

The CompanyJolife AB, a wholly owned company by Stryker Inc, develops and markets the LUCAS ™ Chest Compression System, with related accessories for the global market. LUCAS ™ is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR).Travel Percentage: 10%

Stryker

Ansök nu