Boston Scientific Medical Safety Specialist II 

United States, Minnesota 

203137555

About the role:

Role manages surveillance processes across a wide range of coronary artery disease states. Completes accurate, timely, and consistent medical assessment of adverse events and potential adverse events in order to provide medical expertise, objective oversight and ensures safety vigilance throughout the total product lifecycle. Major interfaces include: Clinical, Regulatory, Quality, Post Market Surveillance, Complaint Management Center and functional management. Performs work under limited supervision of the Medical Safety Manager/Medical Director.

Your responsibilities will include:

• Uses knowledge and experience of clinical medicine to understand and evaluate the interface of medical devices to patients and users. Note: support of specific product families may require enhanced technical expertise of both product and supporting systems.

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

• Represents Medical Safety at multi-functional team meetings, such as complaint trend meetings.

• Identifies potential safety signals for monitoring and trend analysis.
• Performs medical review and assessment of adverse events, sources of which include but are not limited to clinical trials, complaints and Medical Device Reports (MDRs).
• Performs pre-scheduled and ad hoc analyses of data from multiple sources and presents data by communicating accurate, succinct summaries at team and cross functional meetings.

• Applies working knowledge of medical device regulations and standards (globally).
• Coordinates requests from multiple function for media/medical reviews and medical safety related asks, distributing and assigning the right Medical Safety personnel.

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
• 5+ years of experience in clinical/scientific research, preferably with medical device clinical trials preferred
• Understanding of relevant regulations and guidelines for medical device safety, such as those from FDA, EU, and other regulatory bodies
• No sponsorship requirements

Preferred qualifications:

• Direct patient care in Cardiology
• Experience with medical device clinical trials
• Post Market Surveillance experience preferred
• Proven ability to work well in a team and influence without authority

Maximum Salary: $ 132000

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.