Regulatory Affairs Specialist

hace 8 horas


San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

Company Overview:

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Boston Scientific Corporation is a leading global medical device company that empowers healthcare professionals to transform lives through innovative technologies.

We're committed to delivering high-quality solutions that improve patient outcomes and advance the field of medicine.

About the Role:

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This role plays a critical part in our Regulatory Affairs team, collaborating with cross-functional partners to drive process improvements and efficiencies.

As a Regulatory Affairs Specialist, you'll be responsible for supporting global regulatory processes, including assessments for requirement changes and CAPA activities.

You'll work closely with division and country regulatory affairs teams to gather information, identify opportunities for improvement, and support the development of regulatory strategies.

Key Responsibilities:

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  • Collaborate with division and country regulatory affairs teams to gather information related to filling process gaps and edit opportunities for efficiencies.">
  • Support regulatory standard operating procedures and work instructions.">
  • Assess 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.">
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Required Qualifications:

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  • 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.">
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Preferred Qualifications:

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  • ">
  • 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.">
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What We Offer:

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A competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.

Join Our Team:

">

At Boston Scientific Corporation, we empower healthcare professionals to transform lives through innovative technologies.

We're committed to delivering high-quality solutions that improve patient outcomes and advance the field of medicine.

Original Language Code: en



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