Job Description

Job Description

Job Description

Position Summary:

The Regulatory Affairs Intern supports the Regulatory Affairs team by performing various regulatory activities related to the design, development, testing, manufacturing, and market authorization of SMD medical devices, including hardware imaging equipment and AI-based software. Spectral MD’s Regulatory Affairs team ensures products comply with applicable regulations and standards.

Essential Duties and Responsibilities:

• Assist with the development of regulatory submission templates.
• Ensure all new submission documents are filed and updated regularly in the Technical File for each product as appropriate.
• Maintain and update the technical file documentation for commercial products.
• Track Engineering Change Order action items, closeout, and filing.
• Assisted with the revision of documents and records related to regulatory affairs.
• Assist with developing and maintaining a regulatory submission tracking system for all commercial products.
• Assist with developing and maintaining a SharePoint web workspace for the department.
• Assist in other regulatory responsibilities requested by the Regulatory Affairs Director.

Qualifications:

Required education and/or experience:

• Currently pursuing a bachelor’s degree in science or engineering

Knowledge, Skills, and Abilities:

• Experience working in cross-functional organizations.
• Excellent computer skills, including Microsoft Office Suite of products (Word, PowerPoint, Excel, SharePoint, Teams, etc.) and Adobe Acrobat.
• Strong communication and interpersonal skills.

Additional Qualifications (preferred)

Familiarity with the following Regulations/Standards:

• 21 CFR 820
• ISO 13485
• EU MDR 2017/745
• UK MDR 2002

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift- up to 15 pounds at times.

Travel:

None

Equal Employment Opportunity:

Spectral MD, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state or local laws.

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