Senior Regulatory Affairs Specialist 602281

Additional Location(s):USMNMinnetonka; USMAMarlborough; USMNArden Hills; USMNMaple Grove

Diversity Innovation Caring Global Collaboration Winning Spirit High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and highperforming employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:

At Boston Scientific youll discover a place where you can have meaningful purpose improving lives through your lifes work. 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. This role 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 is a hybrid position (in office minimum three days per week) with the flexibility to be located in Marlborough MA or Arden Hills Maple Grove or Minnetonka MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Coordinate compile and submit US and EU regulatory filings for new and modified products including PMAs PMA supplements presubmissions 510(k)s annual reports and MDR CE mark submissions
• 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 crossfunctional 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 presubmission strategy/regulatory pathway development testing requirements clarification and followup 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 onsite audit support
• Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
• Trains to departmental and divisional policies and procedures
• Fosters a work environment of continuous improvement that supports BSCs Quality Policy Quality System and the appropriate regulations for their area of responsibility

Required qualifications:

• A minimum of a Bachelors degree preferably in a scientific or technical discipline
• A minimum of 4 years work experience in Regulatory Affairs or a related discipline (R&D Quality Clinical Medical Affairs Biocompatibility) in medical devices or
• Demonstrated knowledge of FDA EU and/or international regulations
• Demonstrated experience supporting product development and sustaining activities
• Prior experience with a variety of submission types (DeNovo 510(k) PMA EU MDR)
• Experience of regulations applicable to the conduct of clinical trials
• Demonstrated understanding of product development process and design controls
• Proficiency with Microsoft Office applications (Word Excel PowerPoint Teams SharePoint MS Forms)

Preferred qualifications:

• Medical electrical equipment (MEE) experience
• Implantable medical device experience
• 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

#LIHybrid

Requisition ID:602281

Minimum Salary: $82600

Maximum Salary: $156900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see www.bscbenefitsconnect.comwill 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 nonexempt (hourly) nonsales 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 nonsales roles may also include variable compensation i.e. annual bonus target and longterm 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) isnt just business its personal. And if youre a natural problemsolver 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 COVID19 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 COVID19 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 Companys policies or protocols change with regard to COVID19 vaccination.