Senior Clinical Scientist

Additional Location(s): US-CA-Valencia; US-CA-Oakland/East Bay; US-CA-Stockton; US-CA-Sunnyvale; US-CA-Turlock; US-CA-Ventura County; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Marlborough; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Plymouth

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:
The Senior Clinical Scientist will be responsible for authoring clinical evaluation reports (CERs) and reviewing key clinical risk documents (such as Hazard Analyses and Instructions for Use [IFUs]). This position requires a deep understanding of clinical data, regulatory standards, and risk management requirements. The ideal candidate will possess a keen eye for detail, strong analytical skills, and the ability to work collaboratively with cross functional teams to ensure compliance with regulatory requirements and the high standards of patient safety. 

Boston Scientific will not offer sponsorship or take sponsorship of an employment visa at this time.
 

This is a hybrid position (in office minimum three days per week) with the flexibility to be in Valencia, CA or Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 

Your responsibilities will include:

• Develop and author comprehensive Clinical Evaluation Reports (CERs) in compliance with regulatory standards (e.g., MDR).
• Analyze and interpret clinical data to assess the safety and performance of medical devices.
• Ensure CERs are up-to-date, accurate, and aligned with clinical evidence requirements for regulatory submissions.
• Perform periodic updates of CERs, Clinical Evaluation Plans (CEPs), and Post Market Clinical Follow-up (PMCF) Plans.
• Draft well-reasoned clinical responses to inquiries from notified bodies during regulatory reviews.
• Collaborate with regulatory affairs, quality assurance, and product development teams to ensure timely and accurate responses.
• Review and contribute to clinical risk documents, such as Hazard Analyses and Risk Management Reports (RMRs).
• Maintain a strong understanding of relevant regulations and standards (e.g., MDR, FDA) to ensure compliance.
• Work closely with cross-functional teams to support regulatory submissions and align clinical and risk management documentation.
• Contribute to clinical and cross-functional process improvements and maintain knowledge of relevant work instructions and standard operating procedures.

 

Required qualifications:

• Minimum Masters or PhD degree in a relevant field (i.e., Life Sciences, Biomedical engineering) with 5 years of related work experience 
• Minimum 3 years’ experience in authoring Clinical Evaluation Reports (CERs), drafting clinical responses to notified bodies, and working with clinical risk management documentation
• Strong analytical and problem-solving skills, with the ability to interpret complex clinical data

 

Preferred qualifications:

• Preferred experience with neuromodulation and interventional spine therapies

 

 

 

Requisition ID: 597391

Minimum Salary: $84000 

Maximum Salary: $159600 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any