Senior Regulatory Affairs Specialist - Urology

Boston Scientific

  • Irvine, CA
  • $86,600 per year
  • Permanent
  • Full-time
  • 2 months ago
Additional Location(s): US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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:The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures.The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA.Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.Your responsibilities will include:
  • Develops and implements regulatory strategies for new and modified products.
  • Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations
  • Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
  • Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
  • Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
  • Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions)
  • Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
  • Trains to departmental and divisional policies and procedures
  • Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives
  • Fosters a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility
Required qualifications:
  • A minimum of a Bachelor's degree, preferably in a scientific or technical discipline
  • A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
  • Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices
  • Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices
  • Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices
Preferred qualifications:
  • Demonstrated experience of regulations applicable to the conduct of clinical trials
  • Prior experience with regulatory submission writing
  • Demonstrated understanding of product development process and design controls
  • Demonstrated knowledge of FDA, EU and/or international regulations
  • Ability to manage several projects simultaneously
  • Effective research and analytical skills
  • Excellent written and oral communication, technical writing and editing skills
  • Ability to work independently with minimal supervision
  • Strong interpersonal and influencing skillsProficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)
#LI-HybridRequisition ID: 608588Minimum Salary: $86600Maximum Salary: $164500The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see --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.

Boston Scientific