United Spinal Association Jobs

Additional Location(s): N/A 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: At Boston Scientific, you'll discover a place where you can find meaningful purpose, improving lives through your life's work. Global Regulatory Affairs Operations team is looking for a dynamic, well-organized leader who can be a contributing member of a global work environment. This individual will report into the Director/Manager responsible for global regulatory, shared and compliance services. Your responsibilities will include: Notified body working group lead on behalf of Global Regulatory Operations (GRO) including but not limited to: Plan and lead monthly, quarterly, and annual notified body meetings (BSI, DEKRA, TUV SUD, GMED) Support uTrack NB Submission Database (NB Submission Tracker) sustaining activities Lead quarterly uTrack review meetings to review NB Feedback metrics and trends Lead activities related to additions/transfers of notified bodies (including audit support) Lead cross-divisional process efficiency initiatives, as needed Influence NB decision process(s), interpretation of regulations, cost management, etc. Build strong and trusted business relationships with internal and external partners Own regulatory SOPs and WIs applicable to this role Lead and operate effectively as the GRO regulatory team lead on assigned projects including global regulatory strategy development and execution, notified body submissions, standards support, and advocacy initiatives. Required qualifications: Minimum of a bachelor's degree, preferably in a scientific or engineering discipline Minimum of 10 years of medical device, regulatory experience ideally with notified bodies. Preferred qualifications: Master's degree in regulatory affairs Experience in regulatory affairs with a global focus Ability to effectively manage multiple projects Strong written and oral communication skills Strong proficiency with Microsoft Excel, Word, PowerPoint, and databases such as PLM Requisition ID:585317 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 prohibited substance freeworkplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that t e 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. 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. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran