Jobs · Massachusetts

Principal Medical Safety Specialist - CRMDx

Boston Scientific · Marlborough, MA · 1 mo ago
Hybrid$102k/yrFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule headings only if content exists. We must not repeat job title. Must not include Job ID/requisition numbers as headings; can fold minor metadata into short p or drop. Remove boilerplate: Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance (maybe part of intro but not needed). Also remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. We need to preserve all substantive info: location(s), description, responsibilities, qualifications, preferred qualifications, salary range, work model, sponsorship, relocation, etc. We need to decide sections: About the role (the paragraph after "About The Role"), Responsibilities (list), Requirements (maybe required qualifications), Qualifications (maybe preferred?), Skills (maybe combine?), Benefits (none specific), Pay (salary range), Schedule (work model). Also maybe location as a short p. We must not create sections with filler like "commensurate with experience". For Pay we have salary range; we can include that. For Schedule we have hybrid work model requiring at least three days per week. That's substantive. Benefits: posting mentions core and optional employee benefits but not specifics; we should not create Benefits section unless specific content. It says "the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location". That's not specific benefit details, so we should not create Benefits section. Skills: we could extract from qualifications: strong clinical judgment, analytical skills, technical writing, verbal communication, ability to build cross-functional relationships, etc. Could be a Skills section. But we must prefer few substantive sections over many thin ones. Could combine Requirements and Qualifications into one? But spec says use headings for those categories if content exists. We have Required qualifications and Preferred Qualifications. Could make a "Requirements" section for required qualifications, and a "Qualifications" section for preferred qualifications (or "Preferred Qualifications"). However spec list includes Requirements, Qualifications, Skills. Could treat Required as Requirements, Preferred as Qualifications, and Skills maybe derived from both. But to avoid thin sections, maybe we combine Required and Preferred into Qualifications? But spec says use headings for those categories if content exists. It's okay to have both Requirements and Qualifications if they have substantive content. We must not repeat job title. Must not put Job ID/requisition numbers as headings; we can drop them or put in short p. We'll drop them. We need to preserve location(s): Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough. Also maybe primary location not given; we can include location info in a short p. We need to remove duplicated lines, boilerplate like "Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance". Also remove EEO statements, etc. Let's extract substantive paragraphs: Intro: "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." Then "About The Role Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. The Principal Medical Safety Analyst provides medical and clinical safety expertise across the total product lifecycle for cardiology and electrophysiology products and therapies. This role performs medical assessments of adverse events, evaluates emerging safety signals and product performance trends, and provides clinical input into risk management, post-market surveillance and patient safety decisions. As a Medical Safety subject matter expert, this individual partners closely with the Medical Director and cross-functional teams across Quality, Regulatory, Clinical, R&D, Medical Affairs and Commercial functions to evaluate complex safety issues and support informed benefit-risk and patient safety decisions." Then "Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time." Then responsibilities list (bulleted). Then qualifications required (bulleted). Then preferred qualifications (bulleted). Then salary range. We need to output HTML with headings

for each section. We'll have:

Location: US-MN-Arden Hills; US-MA-Marlborough

maybe.

About the role

...

Responsibilities

  • ...

Requirements

  • ...
(required qualifications)

Qualifications

  • ...
(preferred qualifications)

Skills

maybe we can extract skills from both required and preferred: strong clinical judgment, analytical skills, technical writing, verbal communication, ability to build cross-functional relationships, influence without formal authority, etc. Could be a separate section but might be thin. Could combine into Requirements/Qualifications. But spec says we can include Skills if we have content. We have enough to make a decent list. We could also include Pay section:

Pay

Salary range: $102,100 – $194,000 (actual compensation varies based on location and experience).

Schedule:

Schedule

Hybrid work model: required to be in the local office at least three days per week.

We should not include Benefits section. We must not include boilerplate like "At Boston Scientific, we’ll give you the opportunity..." maybe that's okay as part of About the role? Actually that is generic intro; could be part of About the role or we could keep it as a brief intro before sections. The spec says use

for section headings; we can have a leading

for general overview not under a heading. That's fine. We need to ensure we don't repeat job title. Not include "Principal Medical Safety Analyst" as heading. It's okay to appear in paragraph. We must not include Job ID/requisition numbers as headings; we can drop them. We must not include duplicated lines. Let's craft the HTML. We'll need to escape any special characters? Not needed. Let's write:

Location: US-MN-Arden Hills; US-MA-Marlborough

About the role

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. The Principal Medical Safety Analyst provides medical and clinical safety expertise across the total product lifecycle for cardiology and electrophysiology products and therapies. This role performs medical assessments of adverse events, evaluates emerging safety signals and product performance trends, and provides clinical input into risk management, post-market surveillance and patient safety decisions. As a Medical Safety subject matter expert, this individual partners closely with the Medical Director and cross-functional teams across Quality, Regulatory, Clinical, R&D, Medical Affairs and Commercial functions to evaluate complex safety issues and support informed benefit-risk and patient safety decisions.

Responsibilities

  • Serve as a Medical Safety subject matter expert on cross-functional teams supporting product development, risk management, post-market surveillance, quality investigations and remediation activities.
  • Apply advanced clinical and technical knowledge of cardiology, electrophysiology and cardiac implantable electronic devices (CIEDs) to assess device safety, product performance and potential patient impact.
  • Perform medical review and assessment of adverse events and potential adverse events from clinical trials, post-market complaints, Medical Device Reports (MDRs) and other relevant data sources.
  • Lead the evaluation of complex or emerging safety signals, trends and product performance concerns, providing clinical assessments and recommending appropriate escalation or risk mitigation.
  • Provide medical expertise for complaint review boards, corrective and preventive actions (CAPAs), nonconforming event processes (NCEPs), product investigation reports (PIRs) and other applicable quality system processes.
  • Analyze data from multiple sources and communicate concise, clinically meaningful safety assessments and recommendations to the Medical Director, cross-functional teams and leadership.
  • Provide medical review and input for risk management documentation, labeling, instructions for use (IFUs), product safety communications, post-market surveillance and regulatory deliverables.
  • Review promotional, educational and sales training materials for medical and clinical accuracy, as applicable.
  • Identify opportunities to improve Medical Safety processes and practices.
  • Apply knowledge of applicable global medical device regulations, standards and reporting requirements.

Requirements

  • Bachelor's degree in health care, life sciences or a related field.
  • Active professional licensure as a registered nurse (RN), advanced practice registered nurse/nurse practitioner (APRN/NP) or physician assistant (PA), as applicable.
  • Minimum of 5 years' direct patient care experience, including a minimum of 2 years' experience in cardiology and/or electrophysiology with advanced CIED interrogation and troubleshooting experience.
  • Strong clinical judgment and analytical skills, with the ability to interpret complex medical, scientific and product performance information.
  • Demonstrated ability to make sound independent decisions, navigate ambiguity, manage competing priorities and lead complex work with minimal supervision.
  • Excellent technical writing and verbal communication skills, with the ability to clearly communicate complex clinical and safety information.
  • Demonstrated ability to build effective cross-functional relationships and influence without formal authority.

Qualifications

  • Recent experience in a field-based clinical role providing clinical and technical support for CIED implant procedures.
  • Advanced experience with cardiac rhythm management (CRM) technologies, including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, subcutaneous implantable cardioverter-defibrillator (S-ICD) systems, leadless pacing systems, cardiac monitoring systems, and device interrogation and troubleshooting.
  • Minimum of 2 years' experience in Medical Safety, Clinical Research, Clinical Quality or a related medical device function.
  • Experience with safety signal evaluation, risk management, post-market surveillance, quality investigations and/or benefit-risk assessments.
  • Working knowledge of global medical device regulations and requirements.
  • Experience working within a regulated medical device quality system and across multidisciplinary teams.

Skills

  • Strong clinical judgment and analytical skills.
  • Ability to interpret complex medical, scientific and product performance information.
  • Technical writing and verbal communication proficiency.
  • Ability to build effective cross‑functional relationships and influence without formal authority.
  • Knowledge of global medical device regulations and reporting requirements.
  • Experience with CIED interrogation, troubleshooting and CRM technologies.

Pay

Salary range: $102,100 – $194,000 (actual compensation varies based on location and experience).

Schedule

Hybrid work model: required to be in the local office at least three days per week.

We should also include work model, sponsorship, relocation info maybe under Schedule or a separate section? The spec says include Schedule section only if posting actually states them. It does state hybrid work model

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