Senior Regulatory Affairs Specialist

Boston Scientific Gruppe; Marlborough (MA); On-site; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific in Marlborough, MA is seeking a Senior Regulatory Affairs Specialist to support regulatory submissions and ongoing compliance for Class III products, including active implantable devices. The role collaborates with R&D, manufacturing, clinical and quality teams to develop regulatory strategies for US, EU, and international markets.

The candidate will have a bachelor’s degree in a scientific field and at least 4 years of regulatory experience, with 510(k) submissions and EU MDR

Qualifications

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

Responsibilities

• Reviews change notifications and regulatory impact assessments for product and manufacturing changes.
• Supports coordination, drafting, and submission of US and EU regulatory filings for Class III products.
• Provides technical reviews of test protocols and reports.
• Assesses labeling materials, including Instructions for Use.
• Represents Regulatory Affairs on cross-functional project teams.
• Works with international Regulatory colleagues on global filings and strategic initiatives.

Skills

Regulatory affairs

510(k) submissions

EU MDR

International registrations

Education

Bachelor's degree in a scientific field

Tools

Microsoft Office

Job description

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 Senior Regulatory Affairs Specialist position (hybrid work mode) 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.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. We will consider candidates from the following office locations: Irvine, CA, Marlborough, MA, Arden Hills, MN, or Maple Grove, MN. 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

Minimum Salary: $89200

Maximum Salary: $169500

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

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 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. 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.

Nearest Major Market: Boston
Job Segment: Regulatory Affairs, Compliance, Product Development, Drafting, Neurology, Legal, Research, Engineering, Healthcare