Senior Product Risk Specialist

Senior Product Risk Specialist

In this role, you will play a pivotal part in ensuring the safety and clinical compliance of Boston Scientific's global product portfolio. You will be responsible for the analysis, documentation, and communication of clinical product risk across the project and product lifecycle. This includes detecting safety signals, assessing risk, and guiding teams in maintaining alignment with regulatory and corporate standards. Your work will directly support our mission to transform lives through innovative medical solutions that improve the health of patients around the world.

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.

Your responsibilities will include:

• Produce and maintain Clinical Evaluation Reports (CERs) for the global product portfolio in accordance with company SOPs and applicable regional regulations.
• Collaborate with cross-functional partners to support clinical risk analysis and enhance documentation quality.
• Conduct and analyze literature searches to interpret and summarize harms, hazards, alternative therapies, and device-specific benefits for risk assessment.
• Identify the need for and generate clinical risk-related documents for commercial or in-development products to meet both internal and external regulatory requirements.
• Act as a liaison between the Clinical Product Risk function and cross-functional project teams, ensuring effective communication of relevant information.
• Collaborate with Clinical and R&D functions to develop consistent clinical deliverable criteria and rationalize the need (or absence) of clinical trials.
• Serve as a mentor and subject matter expert in clinical product risk activities; provide consulting support on complex projects and product grouping strategies.
• Represent the function as a product SME during audits (FDA, Notified Body, and internal), including preparation of documentation and CAPA responses.

Required qualifications:

• A bachelor's degree and minimum of 3 years' experience in life sciences, engineering, or a related field.
• Or minimum of 7 years' experience in the respective field without a degree.
• Medical and/or technical writing experience.

Preferred qualifications:

• Experience in the medical device industry.
• Knowledge of therapeutic areas and device classifications.
• Strong ability to collaborate cross-functionally and at all organizational levels.
• Proven skills in interpreting and synthesizing clinical and commercial data.
• Excellent attention to detail and strong organizational skills.
• Solid understanding of business procedures, quality systems, and regulatory compliance.

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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.