Scanlan International, Inc. · 16 hours ago
Regulatory Affairs Intern
Scanlan International, Inc. is seeking a Regulatory Affairs Intern to assist the team in researching and reviewing clinical information related to medical devices. The intern will help maintain technical documentation and support various regulatory activities required to market products worldwide.
Health CareManufacturingMedical
Responsibilities
Assist in post-market surveillance system
Assist in updating Technical Files and Risk File based on Post-Market Surveillance
Research clinical publications regarding Scanlan medical devices
Review of business unit reports for product performance and safety trends
Assist in documenting clinical evaluations
Assist in coordination of regulatory activities required to market products worldwide
Assist in medical device CAPA/complaint management
Assist the organizing and filing medical device submissions, registrations, listings, licenses, certifications and records
Attending regulatory meetings and seminars (i.e. Lifesciences Alley, RAPS, ASQ)
Reading regulatory/news publications
Assist in preparing Certificates to Foreign Governments (CFG) or other documentation required to export products from the U.S
Assist in coordination of activities required to meet the requirements of the FDA and U.S. Customs and Border Protection (CBP)
Qualification
Required
Pursuing a Bachelor of Arts or Science degree in life sciences or other related field
Previous work or intern experience
Excellent reading and writing skills with attention to detail is required for regulatory filings, documentation and incident reports
Intermediate to advanced proficiency with Microsoft Office
Ability to exercise appropriate discretion to prevent inappropriate disclosure of confidential information
Excellent interpersonal and communication skills to effectively work with regulatory agents and customers
Good decision making skills to avoid regulatory compliance risks, delays or inability to market new products
Preferred
Relevant course work in medical device regulatory requirements
Interest in collecting, analyzing, and reporting clinical data and field experience regarding medical devices
Company
Scanlan International, Inc.
Since 1921, Scanlan International has designed and manufactured superior surgical products to meet the ever changing technology of the medical industry.
H1B Sponsorship
Scanlan International, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageRecent News
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