Remote Sr Regulatory Affairs Spec
Remote Boulder, CO 80301 US
Job Description
HM's Top Needs:
1. Solid experience in handling sustaining engineering activities for medical devices (reviewing change orders such as manufacturing site transfer, product modification, etc.). The Sr. RA Specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide.
2. Solid experience in authoring regulatory submissions and assessments (e.g., 510(k), letter-to-file, EU Technical File/Design Dossier, etc.).
3. Ability to manage multiple projects and prioritize tasks on day by day basis in order to meet project schedules
Education Required:
• Bachelor's Degree
• Minimum of 4 years of regulatory experience with Bachelor’s degree
• Minimum of 2 years of regulatory experience with an advanced degree
Years’ Experience Required:
• Minimum of 4 years of regulatory experience with Bachelor’s degree
• Minimum of 2 years of regulatory experience with an advanced degree
POSITION RESPONSIBILITIES:
• Define the regulatory strategy and manage regulatory submission activities for product modifications/transfer, considering both domestic and international regulations
• Provide regulatory affairs support to sustaining engineering
• Prepare US regulatory documents (e.g., letter to file) and technical documents to support the CE mark and other international submissions
• Provide product/change information to international regulatory affairs teams to enable the development of strategies and requirements and communicate that information to business teams
• Support international product registrations as needed
• Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
• Interface with engineering, quality, marketing, and other functions as needed to fulfill responsibilities
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
• Perform other duties as requested
Must Have: Minimum Requirements:
• Bachelor's Degree
• Minimum of 4 years of regulatory experience with Bachelor’s degree
• Minimum of 2 years of regulatory experience with an advanced degree
• Experience authoring regulatory submissions (e.g., 510(k), EU Technical Files/Design Dossiers)
• Experience in 510(k), Technical Files/Design Dossier
Nice to Have:
• Degree in a scientific discipline
• Working knowledge of IEC 60601-series standards
• Prior experience with software-driven devices
• Solid interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”
• Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Advanced degree preferred
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