Principal Product Risk Specialist

Additional Location(s):US-MN-Maple Grove

About the role:

Responsible for the analysis and communication of clinical product risk across the project and product lifecycle. Provides guidance in safety signal detection and assessment to communicate safety risks to project teams and senior management. Ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to safety risk management.

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 (e.g., FDA
  510(k)/PMA, EUMDR, 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 backroom documentation and CAPA responses.

Work Mode:

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.

Relocation Assistance:

Relocation assistance is not available for this position at this time.

Visa Sponsorship:

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

Required Qualifications:

• 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
• Experience writing multiple Clinical Evaluation Reports (CER)

Preferred Qualifications:

• 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.

Requisition :611112

Minimum Salary: $103700

Maximum Salary: $197000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see  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 overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may 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.

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.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural…