What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst CRO?
Responsibilities
- Supports necessary regulatory activities required for product market entry.
- Preparation of regulatory submissions for Electrophysiology Mapping and Imaging devices to achieve departmental and organizational objectives.
- Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.
- In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
- Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
- Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
- Supports the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Client customers.
- May interface directly with FDA and other regulatory agencies if so directed.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities as assigned.
- Bachelor's degree (or equivalent).
- 4 years' experience in a regulated industry (e.g., medical products, nutritional).
- Higher education may compensate for years of experience.
- Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
