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Boston Scientific is seeking a Regulatory Affairs Specialist I to support medical device regulatory activities in Peru and the Andean region. In this role, you will coordinate regulatory submissions, maintain accurate regulatory documentation, and manage product lifecycle activities including registrations, renewals, and changes. You will collaborate with cross-functional teams (Quality, Supply Chain, Marketing, Clinical) to gather required documentation, respond to health authority questions, and ensure regulatory activities remain organized, traceable, and on schedule. This is an opportunity to contribute to regulatory operations across Andean markets while building expertise in medical device compliance and health authority interactions.
Boston Scientific is a global medical technology leader with over 45 years of experience, providing high-performance solutions across cardiovascular, respiratory, digestive, oncological, neurological, and urological disease areas.
REQUIREMENTS:
- Minimum 2 years' experience in Regulatory Affairs or the medical device field
- Bachelor's degree in biomedical engineering, pharmaceutical chemistry, or related field; or another degree with demonstrated experience in medical device Regulatory Affairs
- Experience working with medical device regulatory documentation and product lifecycle activities (registrations, renewals, changes)
- Strong attention to detail and organizational skills with ability to manage multiple priorities
- Basic functional English proficiency, with ability to participate in meetings and understand technical documents (certificates, IFUs, labeling, technical files, emails)
PREFERRED QUALIFICATIONS:
- Experience supporting regulatory submissions in Andean markets and/or working with local affiliates or distributors
- Familiarity with quality systems and document-control practices in regulated industries
- Strong Microsoft Excel skills for maintaining trackers and preparing status reports
