Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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 this role:
The Global Medical Safety team acts with the highest integrity to ensure the safe use of BSC products. This is achieved through oversight of safety activities within the divisions of BSC and by ensuring industry leading collection, interpretation and reporting of safety data occurs. The team provides guidance to facilitate inclusion of safety considerations throughout the product life-cycle. Within Global Medical Safety, we act as a corporate steward with the purpose of aligning the divisional medical safety teams in their efforts to promote patient safety in conjunction with the utilization of BSC medical devices.
The Medical Safety Fellow is responsible for conducting activities to inform, connect and advance the company’s Global Medical Safety organization. Through coordination with enterprise-wide partners, this role will lead efforts to create, implement, harmonize, and improve medical safety operations. Through their strong leadership, communication, and collaboration, the Medical Safety Fellow will ensure that activities managed by the team are carried out consistent with legal and regulatory standards and applicable company policies and procedures.
Your responsibilities will include:
- Provide subject matter expertise and support, as needed, to divisions regarding safety activities.
- Represents Medical Safety in cross-functional working groups on matters affecting patient safety in the functional areas such as clinical studies, post market surveillance, and risk management.
- Serves as a key resource on medical, scientific, technical, and therapeutic areas supporting operational strategies, objectives, and goals.
- Recognizes and directs organizational development needs and opportunities aimed at continuous improvement across the Medical Safety function.
- Acts in a manner to bring alignment to Medical Safety activities across divisions.
- Conducts exploratory analyses of medical data and data extraction collaborating with Medical Directors, clinical, global medical safety, quality and product development teams.
- Contributes medical relevance to risk assessments and quality risk management reviews, analyses and processes such as FMEAs, DFUs, CRBA/CESs, MESL, PIRs, HHAs, HAs and CAPAs.
- Ensures comprehensive, integrated analysis of potential safety issue.
- Drafts, maintains, and implements quality system documentation in support of Medical Safety operational activities.
- Leading change through collaboration across divisions and cross-functional areas within the organization.
What we’re looking for in you:
- Bachelor’s Degree
- 7+ years of clinical experience within any combination of direct patient care, clinical studies, clinical research, medical device, medical safety, etc.
- Bachelor’s and/or Master’s degree with a preference towards nursing or another medical profession (e.g. medicine, pharmacy, biological science, etc.)
- Strong medical background with the ability to understand complex disease states and different treatment modalities
- Sufficient understanding of basic science concepts to understand medical device components and function
- Demonstrated ability to clearly and effectively communicate verbally and in writing
- Demonstrated ability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; ability to balance analysis with decisiveness
- Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
- Demonstrated management skills with an ability to coach, lead, and inspire
- Communication, change management and collaboration skills across all levels of the organization
- Technical and/or medical writing skills
- Solid critical thinking and problem-solving skills
- High attention to detail and accuracy
- Strong knowledge of industry standards as well as all applicable laws and regulations
- Experience following standard operating procedures (SOP) and work instructions (WIs) in a quality environment
Requisition ID: 483341
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 is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.