Regulatory Affairs Specialist 1 - Regulatory Affairs

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.

About the Role 

As a member of our Regulatory Affairs team, you will support medical device regulatory activities by coordinating submissions, maintaining accurate regulatory documentation and helping manage product lifecycle activities, including registrations, renewals and changes. You will collaborate with cross-functional teams to gather required documentation, respond to health authority questions and help ensure regulatory activities remain organized, traceable and on schedule. 

This role offers an opportunity to contribute to regulatory activities across Andean markets while partnering with teams including Quality, Supply Chain, Marketing and Clinical. 

Required qualifications: 

• Minimum of 2 years' experience in Regulatory Affairs or the medical device field. 
• Bachelor's degree in biomedical engineering, pharmaceutical chemistry (Química Farmacéutica) or a related field; or another degree with demonstrated experience in medical device Regulatory Affairs. 
• Experience working with medical device regulatory documentation and product lifecycle activities, including registrations, renewals and changes. 
• Strong attention to detail and organizational skills, with the ability to manage multiple priorities. 
• Basic functional English proficiency, with the ability to participate in meetings and understand technical documents, including certificates, IFUs, labeling, technical files and 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. 

Requisition ID: 634414

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.