Specialist I, Reg Affairs

Título del trabajo: Specialist I, Reg Affairs

Compañía: Boston Scientific

Descripción de funciones: Additional Locations: N/A 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. Team Purpose: 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 partners with other functions to bring forward process improvements and efficiencies in the Regulatory Affairs / Product Approvals space. Key Responsibilities: Support process and sub-process stewards and process owners for global regulatory processes, responsibilities include the following: Collaborate with division and country regulatory affairs to gather information related to filling process gaps and edit opportunities for efficiencies. Support regulatory standard operating procedures and work instructions. Support assessments for global requirement changes (including standards) and collaborate with cross-functional partners on changes to the quality system as needed. Support CAPA and NCEP correction and solution activities. Support regulatory strategy and execution on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions. Required Qualifications: Minimum of a Bachelor’s degree or equivalent work experience, 0-2 years’ of experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, pharmaceutical industry, or health care industry Preferred Qualifications: Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485) Degree or work experience in a scientific or technical discipline Excellent written and oral communication, technical writing and editing skills Excellent research and analytical skills Ability to support multiple projects simultaneously Working knowledge of FDA, EU and/or international medical device regulations Ability to read and interpret global regulations and standards General understanding of product development process, design controls and quality system regulations Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint). Advanced proficiency in Excel highly desired Requisition ID: 558230 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) isn’t just business, it’s personal. And if you’re a natural problem-solver 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!

Ubicación: Heredia

Fecha del trabajo: Wed, 22 Feb 2023 23:15:15 GMT


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