Senior Regulatory Affairs Specialist - Endoscopy – Boston Scientific – Jobs in Marlborough, MA | OpenJobs AI

Job Details

Overview Company

Senior Regulatory Affairs Specialist - Endoscopy

$89200-$169500/y

Boston Scientific

2 days ago

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HybridFull-timeMid

Summary

Boston Scientific is seeking a Senior Regulatory Affairs Specialist - Endoscopy to join their team in Marlborough, MA. The role involves developing regulatory strategies and supporting new business development efforts for medical devices in the Endoscopy division.

About the Role

As a Senior Regulatory Affairs Specialist, you will be responsible for developing and implementing regulatory strategies for new and modified medical devices, providing regulatory guidance for OEM and Contract Manufacturer partnerships, and acting as a liaison for product registration in various international markets. You will also draft and submit regulatory filings, review device labeling for compliance, and support global submissions while maintaining quality initiatives.

About You

Required:

Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
Minimum of 4 years' experience in Regulatory Affairs within the medical device industry.
Strong working knowledge of FDA, EU MDR, and international medical device regulations.
Prior experience with 510(k) submissions.
Fluent in Mandarin.

Preferred:

Experience preparing and submitting 510(k), PMA, IDE, EU MDR, or international registrations.
Proficiency with Microsoft Office tools.
Strong analytical, research, and problem-solving skills.
Excellent written and oral communication, technical writing, and editing abilities.

Benefits

Competitive salary ranging from $89,200 to $169,500.
Access to the latest tools, information, and training for career advancement.
Support for quality improvement initiatives.

Boston Scientific

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 40 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 health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and follow us on Instagram, Facebook and YouTube. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.

Marlborough, MA