Purpose and Passion Comprehensive Benefits Life-Work Integration Community 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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work. About this role The Global Regulatory Affairs Operations is a strategic partner that delivers innovative,
efficient and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role with be responsible for representing regulatory interests within quality system projects and process changes, process ownership and audit support. Your responsibilities will include Act as sub-process steward and process owner for global regulatory processes, responsibilities include the following Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams. Author, revise and edit regulatory standard operating procedures and work instructions. Lead assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed. Partner with division and country regulatory affairs to identify process gaps and opportunities for efficiencies. Then, initiate and lead projects to address needs. Lead CAPA and NCEP correction and solution activities. Represent function in audit settings by presenting regulatory processes and evidence of compliance Coordinate regulatory strategy and execute on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions What were looking for in you Minimum Qualifications Bachelors degree or equivalent work experience, preferably in a scientific or technical discipline 5 years Regulatory Affairs or related discipline (e.g. Quality Systems, R&D, Quality, Post Market) medical device or pharmaceutical industry Working knowledge of FDA, EU and international medical device regulations Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485) Ability to read and interpret global regulations and standards General understanding of product development process, design controls and quality system regulations Excellent written and oral communication, technical writing and editing skills Excellent research and analytical skills Ability to manage multiple projects Proven leadership, collaboration and influencing skills Willingness to travel to divisions, regions, and corporate headquarters (estimate 15 PERCENT travel) Proficiency with Microsoft Office applications (Teams, Word, Excel, Powerpoint) About us 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 youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.
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