Boston Scientific Senior Clinical Scientist 

United States, California, Santa Clarita 

48342343

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.

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

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.