Clinical Research Scientist (MDR)

Hobson Prior are currently seeking a Clinical Research Scientist (MDR) to join an orthopaedics organisation on a permanent basis located in Oberdorf, Aaurgau. Our client is focused on helping to heal and restore movement for millions of patients.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• The ideal candidate will be responsible for developing and write high quality Post-market Clinical Follow-up (PMCF) plans and reports with minimal supervision. Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where needed.
• Develop a strong understanding of the orthopaedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
• Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies, document / track decisions and risks, and write PMCF Plans.
• Review summaries of clinical evidence and PMCF strategies in other areas of the Technical Documentation for accuracy and completeness. This includes the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR).
• Maintain strong understanding of evolving post-market evidence requirements under EU Medical Device Regulation.
• Where required, foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection. Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
• Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
• You will be responsible for supporting clinical scientific discussions with internal stakeholders within Clinical, Medical, Regulatory, R&D and Marketing to drive support of the clinical and regulatory strategy, communicate evidence needs.
• Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.

Key Skills:

• Advanced technical writing skills is required, with demonstrated experience in writing PMCF (Post-market Clinical Follow-up) plans / reports strongly preferred.
• Previous experience developing strategies to generate clinical evidence is strongly preferred. (called CERs - Clinical Evidence Report).

Requirements:

• A Bachelor's degree in Biological Science or related discipline.
• A minimum of 4 years experience in the medical device industry or healthcare field is required.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.