Site:
Memphis preferred, open to remote candidates so please specify location/time zone on resume
JOB DESCRIPTION:
• Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices
• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets.
• Manage/lead regulatory-driven project, as directed by management.
• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology
• Plan, lead and support for internal and Regulatory agency audits
• Lead and direct engagement with regulatory authorities as required
• Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance
• Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
• Review product labeling to ensure compliance with regulatory requirements
• Other activities as assigned.
Interview Process:
• Teams interview with hiring manager, potentially Project Lead
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
