Position Summary: Performs a thorough regulatory assessment for proposed changes to current products and provides Regulatory support for line extensions and supplier change requests, ensuring compliance with local and regional registration requirements. Conducts an in-depth review of product literature and marketing collateral for all products, with an emphasis on Class II devices, to ensure Regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes.
Essential Functions:- Performs a through regulatory assessment for proposed product changes, including supplier request changes and documents all related activates to remain in compliance
- Demonstrates global regulatory expertise for change assessments with local regulations
- Collaborates with various departments to review the required plans, procedures and regulatory decisions for existing products or line extensions
- Conducts review of product literature and other marketing collateral (presentations, advertisements, social media posts, etc.) to ensure Regulatory compliance
- Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to this role
- Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Typically requires a minimum of 2 years of related experience with a Bachelor's degree; or 1 year and a Master's degree; or equivalent work experience
- Two+ years of related experience in the medical device industry
- Understanding of regulatory requirements throughout the product lifecycle
- Solid understanding of regulatory terminology, pre-market submission types, and requirements
- Able to evaluate regulatory impact of proposed product and process changes
- Capable multi-tasking skills with the ability to project plan and meet deadlines
- Result driven with a sense of responsibility, urgency and ability to perform under pressure
Physical Demands:The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visual abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
