Regulatory Affairs Specialist III - Urology

Boston Scientific; Irvine (CA); Hybrid; USD 79,000 - 152,000; Full time

Job summary

Boston Scientific is seeking a Regulatory Affairs Specialist III for its Urology division. This role involves supporting regulatory submissions and compliance for active implantable devices. The ideal candidate will have a strong background in regulatory affairs and a collaborative spirit to work within a dynamic team environment.

Qualifications

• Minimum 4 years Regulatory Affairs experience in the medical industry.
• Experience with 510(k) submissions, EU MDR or international regulatory registrations.
• Experience with active implantable devices is a plus.

Responsibilities

• Reviews regulatory impact assessments for product modifications.
• Supports the drafting and submission of regulatory filings.
• Acts as liaison for international regulatory projects.

Skills

Regulatory compliance

Technical writing

Analytical skills

Communication

Education

Bachelor’s Degree in a scientific or technical discipline

Tools

Microsoft Office

Job description

Regulatory Affairs Specialist III - Urology

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Regulatory Affairs Specialist III - Urology

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

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 This Role

At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. We offer a collaborative culture that values diversity and prioritizes initiatives that promote awareness and inclusion, celebrating personal, cultural, and demographic differences of our customers, patients, and workforce. In the Urology division, we continually advance the quality of patient care with innovative Urology solutions.

We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged to help support international expansion. In this role, you’ll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams.

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

• Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed
• Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified Class III products
• Provides technical reviews of test protocols and reports
• Assesses labeling materials, including Instructions for Use
• Represents RA on cross functional project teams
• Works as liaison with International BSC Regulatory colleagues on various projects, including providing support with international regulatory filings
• Supports highly technical or major business segment product lines, special projects or strategic initiatives
  
  

Required Qualifications

• A minimum of a Bachelor’s Degree in a scientific, technical, or related discipline
• A minimum of 4years Regulatory Affairsexperience in the medical industry
• Prior experience with 510(k) submissions, EU MDR or international regulatory registrations
  
  

Preferred Qualifications

• Prior experience with PMA submissions or Class III submissions
• Prior experience with active implantable devices, active devices, or long-term implants.
• Working knowledge of FDA, EU and international regulations for medical devices
• General understanding of product development process, design control and quality system regulations
• Ability to simultaneously manage several projects
• Proficiency with Microsoft Office
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
  
  

Requisition ID: 608035

Minimum Salary: $79700

Maximum Salary: $151400

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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing

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