Associate Regulatory Specialist

• As an individual contributor, the function of the Associate Regulatory Affairs Specialist is to support the Regulatory Affairs function and systems

• collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products
• The individual will prepare and submit documentation needed for registrations globally
• This involves regular high-level analysis and interpretation of government medical device regulation and guidance, strategy development, project management of deliverables and tracking through to completion

• Assistance on the development of regulatory strategies for new product development and product changes.
• Compile and submit, in a timely and accurate manner, regulatory documents according to regulatory requirements.
• Assists with the preparation, review, and approval of department SOP s. Support responses to regulatory authorities queries within defined deadlines Manage maintain Regulatory owned technical documentation.
• Manage regulatory activities and act as the primary contact for specific markets.
• May review labeling and promotional material for compliance with local regulations.
• Maintain annual licenses, registration renewals and listings with various health authorities.
• Supports the monitoring and assessment of RA intelligence (regulations, laws, guidance documents, standards) Provides required information (e.g., clinical data) in support of product reimbursement requests.
• Participate on project teams including continuous improvement projects/tasks and partner cross-functionally, as needed.
• Apply appropriate structured problem-solving tools and techniques to given issues such as Fishbone, 3C, A3 etc.
• Support the maintenance and continuous improvement of the Regulatory Information Systems and processes such as MAP, CPLRs, RACR, UDI etc.
• Additional responsibilities as identified to execute the role as described

Essential Functions of the Role**:

Work Experience Requirements

Education Requirements

Specialized Skills/Technical Knowledge:

• Strong written and verbal communication skills Knowledge of regulations and design controls Developing negotiation skills and problem-solving skills
• Ability to work closely with people at multiple levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
• Technical system skills (e.g., word processing, spreadsheets, databases, online research) Ability to manage or lead multiple small projects and deadlines. Ability to identify compliance risks and escalate when necessary.