Boston Scientific Sr Medical Safety Specialist - Endoscopy 

United States, Massachusetts, Marlborough 

641112497

About the Role:

Role manages surveillance processes across a wide range of Gastrointestinal, Endobariatric, and Pulmonary products and disease states. Completes accurate, timely, and consistent medical assessment of adverse events and potential adverse events in order to provide medical expertise and objective oversight, and ensure safety vigilance throughout the total product lifecycle. Major interfaces include Clinical, Regulatory, Quality, Post Market Surveillance, Complaint Management Center, and functional management. Fulfills responsibilities with limited oversight from the Medical Safety Manager and/or Medical Director.

Your Responsibilities will Include:

• Applies knowledge and experience of clinical medicine to a wide range of medical devices in one or more therapeutic areas.
• Receives and analyzes data from multiple sources (clinical trials, complaints, Medical Device Reports, etc.), identifies safety issues, and participates in trend analysis for input into internal and external Medical Safety reports.

• Escalates potential patient safety issues for decision-making and/or potential action by senior leadership.

• Represents Medical Safety at multi-functional team meetings.
• Works closely with Medical Director and Manager to produce clear and concise communication of complex data.
• Seeks opportunities for continuous quality improvement.
• Applies working knowledge of medical device regulations and standards (globally), including EUMDR and EUDAMED requirements

Required Qualifications:

• Bachelor's level degree or equivalent in healthcare/life science related field
• 5+ years of direct patient care experience required. Examples of health-related field professionals include but are not limited to registered nurse, physician’s assistant, and nurse practitioners
• Understanding of relevant regulations and guidelines for medical device safety, such as those from FDA, EU, and other regulatory bodies

Prefered Qualifications:

• Direct patient care in Interventional Endoscopy and/or interventional pulmonology preferred
• 5+ years of experience in clinical/scientific research, preferably with medical device clinical trials preferred
• Post Market Surveillance experience preferred

Maximum Salary: $ 164500

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.