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Boston Scientific · 5 months ago

Principal Product Risk Specialist

Marlborough US-MA, United States | US-MN-Maple Grove

Full-time

Hybrid

Senior Level, Lead/Staff

$104K/yr - $197K/yr

5+ years exp

Boston Scientific is a leader in medical science, dedicated to solving significant health industry challenges. The Principal Product Risk Specialist will analyze and communicate clinical product risk throughout the project and product lifecycle, ensuring compliance with safety risk management standards and guidelines.

Health CareMedicalMedical Device

No H1B

Responsibilities

Produce and maintain Clinical Evaluation Reports (CERs) for the global product portfolio in accordance with company SOPs and applicable regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA, etc.). Collaborate with cross-functional partners to obtain additional input to aid in clinical risk analysis

Analyze literature searches on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature to support risk assessment

Identifies the need for and/or generates clinical risk related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements

Serves as a liaison between Clinical Product Risk function and project team. Clearly communicates pertinent project/function information

Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan

Mentors and serves as subject matter expert in key clinical product risk activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure

Serve as product SME during FDA, Notified Body, and internal audits; prepare back‑room documentation and CAPA responses

Qualification

Clinical Evaluation ReportsMedical Device industry experienceMedicalTechnical writingData analysisInterpretationCross-functional collaborationUnderstanding business conceptsAttention to detailOrganizational skills

Required

A bachelor's degree and 5+ years of professional experience in life sciences, engineering, or related field

Or 10+ years of professional experience in the respective field

Medical and/or technical writing experience required

Preferred

Medical Device industry experience preferred

Therapeutic area knowledge desired

Ability to work cross-functionally at all levels of organization

Proven ability to analyze, interpret and synthesize clinical and commercial data

Attention to detail and strong organizational skills

Understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment and failure to adequately perform tasks can result in noncompliance with governmental regulations

Benefits

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