Hobson Prior are looking for a PMCF Scientist - Medical Device to join a brilliant pharmaceutical corporation on a permanent basis working fully remotely from home anywhere in Europe. Our client is focused on generating healthier societies all around the world.

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

Key Responsibilities:

• Uphold a robust understanding of growing post-market evidence requirements under EU Medical Device Regulation.
• Participate in suitable clarification and distribution of all evidence produced, this involves abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.
• Develop a sturdy comprehension of the orthopaedic device product portfolio and business needs for clinical evidence to meet regulatory needs.
• For the position of PMCF Scientist - Medical Device, you will be responsible for collaborating with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post-market clinical evidence generation tactics that consider evidence needs for EU Medical Device Regulations (EU MDR). You will facilitate clinical evidence reviews with cross-functional team to align on clinical evidence strategies, document/track decisions and risks, and write PMCF Plans.
• The ideal candidate will foster relationships with surgeons, hospitals, and research teams to acquire input into study design, assess study feasibility, and classify sites for study implementation or data collection. Develop strong collaborative relationships with the study core team and any others to guarantee study progress for allocated projects and that matters are recognised and communicated to leaders.
• Work with the Contracts and Payments team to warrant timely implementation of all study agreements and corresponding payments for achieved milestones and deliverables.
• As the PMCF Scientist - Medical Device, you will be accountable for supporting clinical scientific deliberations with internal investors within Clinical, Medical, Regulatory, R&D and Marketing to initiate support of the clinical and regulatory strategy, communicate evidence requirements.
• You will develop 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 consent, investigator brochures, and other study materials where needed.
• Appraise 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).

Key Skills:

• Can operate cross-functionally, have strong communication skills.
• You are able to complete deadlines, capable of working without being micromanaged while still meeting all deliverable.
• Committed to your role and the company.

Requirements:

• Educated at a Bachelor's degree level within a Biological Science or similar field, with at least 4 years of experience in the medical device industry or healthcare field.
• Progressive technical writing skills are needed, with proven experience in writing PMCF plans/reports is preferable but not essential to the role.
• Solid project management skills are required for this role, with a palpable track record of success handling multiple projects at once with minimal supervision.
• Capable of conversing efficiently and function with teams is required for this role.
• Former experience developing tactics to produce clinical evidence is strongly preferred.
• High capacity to build and maintain Microsoft SharePoint sites and any other platforms to facilitate operative team partnership.
• Verified experience in developing / supporting the implementation of complicated project plans within a matrixed setting.
• Train and support internal project owners and teams on a continuing basis to analyse project requests, evaluate project scope, facilitate project prioritisation, report status and deliverables.

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.