Regulatory Operations Specialist

Contract

Are you a regulatory document powerhouse who thrives on precision and process? My client is seeking a Contract Regulatory Operations Specialist to play a critical role in driving compliant, high-quality medical device submissions. This is your opportunity to directly impact global regulatory success by ensuring flawless documentation and submission execution in a fast-paced environment.

Plymouth Meeting, PA

• High-impact contract role supporting medical device regulatory submissions
• Opportunity to work on FDA and EU MDR filings
• Collaborative, compliance-driven regulatory team

• Uploading, formatting, and managing documents within eDMS platforms
• Supporting 510(k), EU MDR technical files, supplements, and annual reports
• Performing quality checks for formatting, naming, and version control
• Assembling eCopy and electronic submissions
• Maintaining submission logs and tracking timelines
• Coordinating document review, approvals, archiving, and audit readiness

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field
• Experience supporting FDA submissions and/or EU MDR documentation
• Proficiency with eDMS platforms such as Veeva Vault, Master Control, or Track Wise
• Strong document control and version management expertise
• Exceptional attention to detail with advanced Word formatting skills

We’d love to see your resume, but we don’t need it to have a conversation. Send an email to  and tell me why you’re interested, or feel free to email your resume. Please include Job#19757.