Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
About the role:
At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest.
Under minimal supervision, the Sr. Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory approvals to the FDA, notified body and other country specific product registrations, specifically around Digital Health. The position is also responsible for ensuring continued compliance with regulatory agency approvals.
Your responsibilities will include:
Represents RA on cross functional product development and manufacturing support teams
Develops domestic and international strategies for regulatory approval of company products
Researches and advises company on country specific international product registration and compliance related requirements
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Coordinates, compiles and submits U.S. and international regulatory filings for new and modified company products, including IDEs, PMAs, PMA supplements, IDE periodic reports, PMA annual reports, CE Mark dossiers and updates, and other country specific product registrations
Technical reviews of test protocols and reports for inclusion in regulatory filings
Assessment of labeling, advertising, and promotional materials for regulatory compliance and support of claims
Works with clinical affairs for reporting of A/E's associated with clinical trials
What we’re looking for in you:
Bachelor's Degree in life sciences, engineering or related field
U.S. and/or International medical device submissions experience
2 – 5+ years regulatory affairs experience or related experience in medical device industry
Demonstrated proficiency with relevant US/International regulatory requirements for medical devices including Quality Systems standards and clinical investigations
Ability to communicate complex ideas clearly and simply both orally and in writing
Demonstrated ability to effectively manage multiple projects and priorities
Team player with excellent interpersonal skills
Basic understanding of medical device regulations
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Previous experience with Class II and/or Class III medical devices submissions is desired
Experience working directly with FDA, notified bodies and/or international health authorities is desired
Exposure to Digital Heath, software
*Level of role will be determined based on candidate's experience
Additional Salary Information: Boston Scientific strives to provide compensation that is competitive in today's market and include competitive core benefits while differentiating ourselves with flexible options that meet individual needs.
Internal Number: 429991
About Boston Scientific
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran.