Senior Clinical Evaluation Scientist
Senior Clinical Evaluation Scientist
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Salary Not Disclosed
1 Vacancy
Job Description
Additional Locations:Belgium-Diegem; France-Voisins le Bretonneux; Germany-Dsseldorf; Italy-Milan; Netherlands-Kerkrade; Spain-Madrid; United Kingdom-Hemel Hempstead
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.
About the role:
This is a highly dynamic role in which you will work in a team environment to develop global evidence-based clinical strategies for cardiology medical devices (Cardiac Rhythm Management) by creating clinical documentation that systematically synthesizes information from multiple data sources. As a Clinical Evaluation Scientist you will plan and develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs. This role applies analytical thought processes and a highly methodical clinical evaluation approach to develop benefit/risk profiles for the Boston Scientific portfolio cardiology devices. A successful candidate has excellent writing skills as well as the ability to work collaboratively with cross-functional partners. Your efforts support product approval indication expansion and claim support and mandated post-market requirements.
Your responsibilities will include:
Compile appraise and evaluate data from multiple sources including clinical trials medical literature design verification/validation data and product complaint data. Compare and align this data with Risk Documentation and product labeling to identify gaps or emergent concerns.
Develop literature search strategies in collaboration with librarians and perform methodical evaluation of medical literature including screening appraisal and extraction of relevant data.
Develop Clinical Benefit Statements in collaboration with medical experts and develop pre- and post-market data collection strategies to support the developed statements.
Create analyses to evaluate product benefit/risk profile safety (e.g. develop a profile of adverse events) and performance. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.
Develop global clinical data strategies in collaboration with leadership and cross-functional partners to support market access for New Product Development Sustaining Product compliance and Design Changes to existing products.
Manage ongoing Design and Quality activities to support necessary changes and/or improvements to devices including assessing the impact to existing clinical data strategies proposing and developing new clinical data activities to meet any identified gaps and coordinating with management to ensure resourcing needs are considered.
Aid in the development and execution of strategies for responses for regulatory submissions.
What were looking for in you:
MinimumQualifications
Bachelors Masters or Advanced degree (PhD research-based MS MD RN DVM) in a scientific medical or engineering field.
6 years professional experience in a scientific engineering medical or medical device space
3 years of experience inat least one of the following: 1) Writing and Developing Clinical Evaluation Plans/Reports and Post-Market Clinical Follow-Up Plans/Reports in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e. EU Medical Device Regulations) relevant Medical Device Coordination Group (MDCG) guidance and harmonized standards; 2) Working in the clinical treatment and management of patients receiving Cardiac Rhythm Therapies including but not limited to: Pacemakers; Implantable Cardioverter-Defibrillators (ICDs); Cardiac Resynchronization Therapy Pacemakers/Defibrillators (CRT-P/Ds); or Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) or 3) Writing Developing Managing and Submitting Regulatory Technical Documentation submissions in accordance with Regulation (EU) 2017/745 of the European Parliament (i.e. EU Medical Device Regulations) to support EU Market access of Cardiac Rhythm Devices
Thorough understanding of different types of clinical evidence (e.g. literature clinical trials real-world evidence etc.) and the benefits and limitations of each type of data.
Experience in strategically applying knowledge of regulations medical knowledge and data types to develop clinical data strategies to support submission.
Analytical skills including strong familiarity with medical literature
Strong medical/scientific writing skills
- Advanced proficiency in English aligned with C1 level or 85-90% proficiency
Preferred Qualifications
3 years of professional experience in multiple of the areas identified above
Experience with/knowledge of with Quality Management System documentation specifically Risk Management Documents (e.g. Hazard Analysis Risk Management Report Risk Management Plan)
Experience with engineering documentation including test protocols test reports and international standards
Requisition ID:610286
As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.
So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre a natural problem-solver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you!
Required Experience:
Senior IC
Employment Type
Full Time
