Job Description

Additional Locations: US-MN-Minnetonka

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.

About the role:

The Senior Clinical Product Risk Specialist is primarily responsible for writing clinical evaluation reports (CERs) and clinical evaluation plans (CEPs) that support new product development and sustaining activities within the BSC Urology and Pelvic Health Division. You will be the clinical representative in cross functional teams partnering closely with Regulatory Affairs, Research & Development, Design Quality Assurance, and Medical Safety.

Your responsibilities include:

* Write CERs and CEPs by evaluating scientific literature, reviewing hazard analyses and other risk documents, reviewing product complaint data, analyzing scientific data, and staying abreast of current clinical practice. Your effort and leadership support product approval, indication expansion, and mandated post-market requirements.
* Provide clinical input to support claims and statements for new product development, post market surveillance, recertification, and business development.
* Interact with regulatory agencies as needed, by providing audit support or addressing clinical queries in support of product safety and performance
* Manage CER and other document timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
* Provide input into hazard analyses, product failure modes & effects analyses, and directions for use for assessment of potential harms and support of product safety and performance.

What were looking for in you:

Minimum Qualifications

* Bachelors degree
* 5+ years of related work experience (Clinical Risk/Safety/Trial/Medical Writing)
* Advanced knowledge of medical terminology
* Ability to review and synthesize medical publications and/or competitive product literature
* Working knowledge of Adobe PDF, MS Word, and Excel
* Ability to use in-depth clinical knowledge in cross functional team meetings

Preferred Qualifications

* Advanced Degree preferred (MS, PhD, PharmD)
* Medical device industry experience
* Understanding of regulatory requirements to conduct clinical risk assessment
* Understanding of scientific research methodologies (clinical investigation design and biostatistics)
* Understanding of information management (experience with relevant databases such as PubMed, Ovid, or Embase)
* Experience with citation management software such as EndNote
* Proven ability to build strong cross group dependencies/relationships
* Proven ability to manage timelines

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.

Requisition ID: 470699