Senior Regulatory Affairs Specialist - WATCHMAN

Your responsibilities will include: ● Bachelor's degree ● Minimum of 5 years' experience in Regulatory Affairs within the medical device industry, including experience supporting SaMD ● Solid understanding of SaMD concepts and regulations, including intended use, classification, multi-function device considerations, and AI/ML integration ● Experience compiling software documentation (requirements, architecture, risk analysis, V&V) for SaMD and both cloud-hosted and on-premise systems, including cybersecurity ● Thorough understanding of product development processes and design controls ● Proficiency in relevant U.S. and EU medical device regulations, including Quality Systems and clinical investigation requirements ● Demonstrated experience preparing a range of regulatory submissions for U.S. and EU (e.g., PMAs, PMA supplements, pre-subs, IDEs, 510(k)s, CE design dossiers, MDR tech files) ● Proven ability to manage multiple regulatory projects and serve as regulatory lead ● Strong technical knowledge of medical devices, procedures, and terminology ● Proficiency with Microsoft Office (Word, Excel, PowerPoint) ● Bachelor's or Master's degree in Computer Science, Engineering, Biological Sciences, or related field ● Deep understanding of GMLP, FDA guidelines, and EU MDR requirements for AI-driven SaMD ● Familiarity with the IMDRF SaMD framework or similar software product development life cycles ● Strong clinical acumen ● Comprehensive knowledge of medical device standards and guidance documents ● Excellent research and analytical capabilities ● Strong organizational and communication skills; ability to synthesize and interpret technical input from various sources ● Leadership and influencing skills with experience mentoring others ● Ability to work independently with minimal supervision ● Experience with Class II and Class III medical devices Requisition ID: 622286 Minimum Salary: $85000 Maximum Salary: $161500 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. 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! 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. 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 identity, 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. 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.