Senior Manager Clinical Evaluation Pre/Post-Market

Position: Senior Manager Clinical Evaluation Pre/Post-Market

Location: Heidenheim, Ulm

Contract: Full time, permanent (However open to part time if needed).

Reporting into: Senior Director Clinical Affairs

Company: Medical devices and wound-care

Background

This opportunity is for a new Senior manager in Clinical Evaluation in Pre or Post-Market- Medical Device to be based in South Germany.

Responsibility

• Define needs regarding clinical safety and clinical performance of the device;
• Evaluate if there are clinical data available and determine equivalence in case of possible equivalence to an existing device
• Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary
• Initiate Clinical Trial if needed (authorization at authorities, authorization ethics committee)
• Supports generation of required documentation to initiate clinical trials (CFRs, Protocol, Investigator brochure, …)
• Generate Clinical Evaluation Reports
• Execution, communication and reporting of feasibility, CE mark and post-marketing studies to enable the company to meet its business objectives

Requirements

• MSc or PhD in life sciences
• Experience working with Medical Devices according to MDD/MEDDEV 2.7.1/ISO14155/ISO13485 standards
• Demonstrable clinical evaluation skills
• Experience in conducting clinical studies
• Knowledge of European regulatory environment
• Knowledge of/experience with medical writing, literature searches, scientific work, risk-benefit assessment, post marketing clinical follow-up
• Fluent in English (plus working knowledge of at least one other European language)

Contact

By clicking “apply” you will be sending your CV to Sebastian Diez at Barrington James. Sebastian is a Specialist European Pharmaceutical Recruiter with broad recruitment experience, a BSc in Biology. Seb will discuss the opportunity in detail with you facilitate your application and will manage the process acting as a link between the company and yourself. He will assist in all elements of the process, facilitate the offer process, keep in contact throughout your notice period and even catch up with you during your first week in your new role.

This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to “sebastian” at sdiez (at) barringtonjames (dot) com alongside a copy of your CV.