Regulatory Affairs Specialist II
2 months ago
At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.
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.
Purpose
Responsible for Regulatory Affairs support of the product sustaining process, submissions, maintenance of regulatory files and regulatory compliance.
Responsibilities
Work as part of a team responsible for regulatory activities at Boston Scientific. Support manufacturing and design sustaining activities by assessing regulatory impact of the change, and provide guidance on regulatory strategies. Review and approve documentation related to product changes through the change notification process. Preparation and maintenance of Technical Documentation. Preparation of submissions such as Annual Reports, 30 Day notices, Notice of Change etc. Support Cork Quality function during external agency audits. Provide regulatory support for Cork Site projects Support strategy and submission activities for new product developmentQualifications & Experience
Degree in Engineering or Life sciences (e.g., Chemistry, Biology, etc.). Medical device regulatory experience desirable Demonstrated execution and organizational skills. Demonstrated ability to handle multiple projects. Excellent verbal and written communication skills. Work successfully within a team environment and as an individual contributor. Flexible and ability to adapt to changing regulatory environment and business needs. Proficient use of technology including MS office programsAbout us
Purpose and Passion – Comprehensive Benefits – Life-Work Integration – Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work.
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
BSCI
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