The Regulatory Affairs Intern will assist the team by researching and reviewing clinical information pertaining to Scanlan medical devices and maintaining the relevant technical documentation in accordance with regulations. They will be involved with essential activities required to market medical devices worldwide.
Position Responsibilities / Essential Functions:
Percentage Time | Accountability |
50% | Post-Market Surveillance Evaluation - Assist in post-market surveillance system
- Assist in updating Technical Files and Risk File based on Post-Market Surveillance
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20% | Clinical Evaluation - Research clinical publications regarding Scanlan medical devices
- Review of business unit reports for product performance and safety trends
- Assist in documenting clinical evaluations
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20% | Regulatory Affairs Coordination - 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
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10% | Medical Device Import/Export - 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)
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QUALIFICATIONS:
Required Qualifications: |
Education: - Pursuing a Bachelor of Arts or Science degree in life sciences or other related field.
Experience: - Previous work or intern experience.
Skills: - 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.
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Preferred Qualifications: |
Education: - Relevant course work in medical device regulatory requirements.
Experience: - Interest in collecting, analyzing, and reporting clinical data and field experience regarding medical devices.
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