Regulatory Affairs Specialist

Description

Position Summary:

Supports and executes regulatory compliance processes in collaboration with cross-functional teams and leadership, ensuring alignment with NeoCoil’s QMS and applicable regulatory requirements. Supports departmental efforts for compilation and submission of applicable documents in accordance with NeoCoil QMS requirements and jurisdictional requirements. 

Job Duties and Responsibilities:

• Acts as a liaison within NeoCoil for educating employees and stakeholders on regulations, procedures, and policies.
• Executes assigned regulatory processes, including administrative tasks, data analysis, trend identification, and reporting.
• Supports the evaluation of changes to regulations, international standards, customer requirements, products, processes, and QMS documentation. 
• Identifies and communicates improvement opportunities and/or escalates weaknesses/gaps in product, process, and quality management system documents to ensure NeoCoil achieves and maintains the necessary levels of compliance.
• Maintains data and files for future reference, particularly in the event of an audit by a regulatory agency; assists in preparation/compilation of regulatory submissions.
• Executes core duties and responsibilities of the role in accordance with the established skills competencies.
• Performs Product Quality Engineer responsibilities as assigned, ensuring alignment with quality and regulatory expectations.
• All other duties, as assigned.

Requirements

Essential Skills and Experience:

• Proficient in all essential skills and experience required of the Product Quality Engineer role.
• Bachelor’s degree in regulatory, engineering, or related field of study, or equivalent combination of training and experience.
• Minimum of 3-5 years of quality or regulatory experience, or combination of 3 years’ experience between quality and regulatory experience is required. Experience in the medical device manufacturing industry is preferred.
• Proficient in understanding and interpretation of written and verbal instructions, directions, and technical information.
• Intermediate computer competency in MS Office (Outlook, Word, Excel, Visio, etc.) and business specific software (e.g., ERP, eQMS) and regulatory services (e.g., web-based standards subscription services, EUDAMED, FDA MAUDE database).
• Influencing people; inspires alignment and action by effectively persuading and motivating others to achieve expected and/or planned process and product outcomes.
• Making complex decisions; solves multifaceted problems with clarity and confidence.

Reporting to this position: No direct reports.

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.