Specialist I, Reg Affairs - Heredia, Costa Rica - Boston Scientific Corporation

Boston Scientific Corporation

Empresa verificada

Heredia, Costa Rica

hace 1 semana

Publicado por:

Andrea Rodríguez

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Descripción

Specialist I, Reg Affairs:

Remote Eligible: Remote Global
Onsite Location(s): Heredia, H, CR
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 crossfunctional 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,
02 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

Requisition ID:558230

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Compliance, Regulatory Affairs, Pharmaceutical, Medical Device, PLM, Legal, Science, Healthcare, Management