Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
General Summary of the Position
The Regulatory Associate II is responsible for overseeing Rhythmlink Regulatory Affairs in the development, implementation, and maintenance of processes and records for domestic and international regulatory compliance. This role supports global regulatory compliance through periodic regulatory submissions, support of external and internal audits, generation and maintenance of technical documentation, and regulatory project management. Success in this role is measured by compliance verified through audits, approval to distribute product lines in global markets, maintenance of current market authorization. This role will participate on multidisciplinary teams to establish appropriate technical documentation and ensure compliance to regulatory requirements.
Essential Functions
(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics. This list of tasks is not a comprehensive listing of all functions and tasks performed by this position. It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)
Knowledge, Skills, and Abilities
Education, Training, and Experience
or
Preferred Experience
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Additional responsibilities and duties will be required depending on a variety of factors.