Regulatory Affairs Associate I

Job Description

Job Description

We are looking for a Regulatory Affairs Associate I to support global submission activities for medical device products from Skaneateles, New York. This Long-term Contract position offers a flexible schedule in a remote work environment and focuses on coordinating regulatory documentation, reviewing technical materials, and helping teams meet international compliance expectations. The role is well suited for someone who can manage details carefully, collaborate across functions, and contribute to regulatory projects with strong organization and communication skills.

Responsibilities:
• Coordinate and assemble documentation packages needed for regulatory submissions across global markets.
• Review scientific, technical, and product-related materials to help ensure submission content is accurate and complete.
• Contribute to regulatory project activities by supporting timelines, deliverables, and follow-up actions.
• Organize and maintain regulatory records in a structured manner that aligns with applicable compliance standards.
• Prepare draft responses to inquiries from regulatory authorities under established plans and guidance.
• Edit, proofread, and format regulatory documents to improve clarity, consistency, and quality.
• Assist with the review and preparation of labeling materials, standard operating procedures, and related departmental documentation.
• Monitor the progress of regulatory documents and communicate status updates to project stakeholders.
• Participate in cross-functional project teams to provide regulatory input and support submission strategy execution.• Bachelor’s degree in a scientific discipline or an equivalent academic background; other degree paths may be considered with relevant training.
• Familiarity with U.S. medical device regulations and exposure to EU device regulatory requirements.
• Understanding of regulatory affairs processes within healthcare or medical device environments is preferred.
• Ability to work effectively with cross-functional teams and interact professionally with external regulatory bodies.
• Strong organizational skills with the ability to manage multiple priorities and meet project deadlines.
• Proficiency in document editing, proofreading, word processing, spreadsheets, databases, and online research tools.
• Effective written and verbal communication skills, along with sound administrative and project coordination abilities.