Medical Safety Specialist II

Additional Location(s):US-MN-Maple Grove; US-MA-Marlborough

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

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.

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.

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 towork well in a team andinfluence without authority

Requisition ID:609384

Minimum Salary:$69500

Maximum Salary: $132000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will 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 problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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 specificprohibited substancetest 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.