Clinical Evaluation Scientist II
7 days ago
We are seeking a highly skilled Clinical Evaluation Scientist II to join our team in Global Regulatory Affairs. As a key member of our team, you will be responsible for ensuring the safety and efficacy of our products through systematic data analysis from multiple data sources.
The ideal candidate will have a strong background in clinical evaluation, analytical thought processes, and excellent writing skills. You will work collaboratively with cross-functional partners to support product approvals and mandated post-market requirements in geographies worldwide, with a focus on the European Union.
This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA or Costa Rica. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Your responsibilities will include:
- Supporting the development of 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.
- Compiling, appraising, and evaluating data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data.
- Developing literature search strategies and methodically evaluating medical literature to support analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events.
- Ensuring alignment of clinical data with risk documentation, and contributing to product labeling.
Required qualifications include a Bachelor's/Master's degree and minimum 5 years professional experience or Advanced degree (PhD, research-based MS, MD, RN/DVM). Analytical skills, including strong familiarity with scientific literature, and proven medical/scientific writing skills are also essential. Preferred qualifications include the ability to understand engineering documentation, including risk documentation, and experience with regulatory body communications.
Boston Scientific is committed to advancing science for life by solving the challenges that matter most in the medical industry. Our mission is to transform 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.
We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and is essential in our work of advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all, and we are an equal opportunity employer.
Boston Scientific maintains a prohibited substance-free workplace and complies with all applicable state and federal law and healthcare credentialing requirements.
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