Boston Scientific

Principal Regulatory Affairs Specialist

Boston Scientific • $106K — $202K *
Marlborough, MA 01752In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in scientific, technical, or related discipline
  • 7+ years of Regulatory Affairs experience in the medical field
  • Experience with capital equipment and single-use medical devices
  • Proficient in 510(k) submissions, EU MDR, and international regulations
  • Knowledge of FDA, EU, and international medical device regulations
  • Ability to interpret global regulations and standards
  • Understanding of product development processes and clinical trial regulations

Responsibilities

  • Provide technical guidance and regulatory training to team members
  • Develop and maintain relationships with device reviewers through strong communications
  • Create regulatory strategies for new and modified medical devices
  • Serve as a liaison for regulatory guidance to new business partners
  • Act as a core member of development teams to ensure regulatory compliance
  • Prepare and submit global regulatory applications
  • Review device labeling and advertising for compliance with regulations

Benefits

  • Comprehensive health and wellness programs
  • Opportunities for professional development and training
  • Access to a vibrant company culture
  • Flexible work schedule to accommodate business needs
  • Support for maintaining Quality initiatives in accordance with policies
  • Involvement in strategic initiatives and special projects
Full Job Description
Additional Location(s): N/A

About the role: At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. In the Urology division, we continually advance the quality of patient care with innovative urology solutions. We have a robust product line and pipeline, and we will continue to make an investment in Urology treatments. 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 and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. The ideal candidate will demonstrate flexibility in their work schedule to accommodate business needs and collaboration across teams

Your responsibilities will include:

  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.


  • 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.


  • Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships.


  • Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration.


  • Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.


  • Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.


  • Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.


  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.


  • Support and maintain Quality initiatives in accordance with BSC Quality Policy.


  • Continuously assess ways to improve Quality.


  • Develops and implements departmental and divisional policies and procedures.


  • 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 7 years Regulatory Affairs experience in the medical industry


  • Prior experience supporting both capital equipment/medical electrical equipment and single-use disposable medical devices.


  • Prior experience with 510(k) submissions, EU MDR and international regulatory registrations.


  • Working knowledge of FDA, EU and international regulations for medical devices.


  • Ability to read and interpret global regulations and standards


  • General understanding of product development process, design control and quality system regulations.


  • General understanding of regulations applicable to the conduct of clinical trials.


Preferred qualifications:

  • Prior experience supporting contract manufactured and/or OEM products.


  • 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: 633802

Minimum Salary: $106800

Maximum Salary: $202900

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.

About Boston Scientific

BTG offers program solutions for small business programs, management workforce development, emerging business growth strategies, training development and delivery strategies, and business planning services.

Boston Scientific Careers

Joining Boston Scientific means becoming part of a global team dedicated to advancing science for life. With a focus on medical solutions that improve the health of patients around the world, Boston Scientific offers unparalleled job opportunities in the healthcare industry. Work You’ll Do At Boston Scientific, your work contributes directly to transforming lives through innovative medical solutions. As a member of our team, you will collaborate with skilled professionals to drive growth and innovation in healthcare. Our commitment to leadership in the industry makes Boston Scientific a place where careers flourish and professional development is taken seriously. Boston Scientific Leadership and Development Programs We are committed to nurturing a culture of growth and leadership. Boston Scientific’s development programs are designed to foster professional skills, leadership qualities, and a deep understanding of the medical devices industry. Whether you’re just starting out with an internship or you’re a seasoned professional, our programs help you achieve your career ambitions. Innovative Work Join a team where innovation is at the heart of everything we do. Boston Scientific is a leader in developing cutting-edge technologies and solutions that address unmet patient needs. By focusing on innovation, we maintain our leadership in the medical field and ensure continuous growth and improvement. Be Part of a Diverse and Inclusive Team At Boston Scientific, we believe that diversity fuels innovation. Our commitment to diversity and inclusion is evident in our hiring practices and the dynamic team culture we cultivate. Employees from various backgrounds bring unique perspectives that lead to better solutions and a more inclusive workplace. Benefits and Opportunities Boston Scientific is dedicated to providing employees with competitive benefits and a supportive environment that values health and well-being. Our benefits package includes comprehensive health coverage, retirement plans, and employee wellness programs, all designed to support your life both inside and outside of work. Explore Career Opportunities Whether you’re looking for an internship, a full-time position, or a leadership role, Boston Scientific offers a range of career paths. Explore job opportunities that match your skills and interests on our Careers page. We are always looking for curious, creative, and driven individuals to join our team. Stay Connected Keep up to date with the latest at Boston Scientific by following our Careers Blog. Gain insights from our team, learn about our culture, and get tips on everything from crafting your resume to acing your interview. Networking and Professional Growth Enhance your career through networking opportunities within Boston Scientific. Connect with leaders, gain industry insights, and build relationships that will help propel your career forward. Our professional environment encourages networking and collaboration, which are key to personal and professional growth. Join Our Team Search open positions at Boston Scientific that align with your skills and interests. We are looking for passionate, innovative, and solution-driven team players ready to make a difference. Start your journey with us today and be part of a company that’s dedicated to transforming lives through science. SEARCH BOSTON SCIENTIFIC JOBS Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at Boston Scientific.
Learn more about Boston Scientific
Size
41,000 employees
Market Cap
$66.3 billion
Industry
Healthcare
Net Income
-$82 million
Founded
1979
5 Year Trend
+7.2%
Revenue
$9.9 billion
NASDAQ
BSX
* Ladders Estimates

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