Manager, Regulatory Affairs

The Regulatory Affairs Manager will assist in establishing and maintaining quality management systems and will work to ensure all members of the organization are aware of the quality system. This position will work to support employee compliance with all international, federal, state, and organizational requirements.

Responsibilities:

• Perform activities and maintain a system for tracking employee training, new hire training, and certification status to comply with federal, state, and international regulatory agencies.
• Maintain and organize regulatory documentation including job descriptions, resumes, regulatory submissions, correspondence with regulatory agencies, and regulatory tracking databases.
• Act as a liaison between the company and regulatory agencies, facilitating communication and ensuring timely responses to inquiries.
• Ensure compliance with document record and change control procedures, including adhering to document and part numbering protocols.
• Maintain an archive of all change requests and individual documents for both new and revised documents including policies, procedures, work instructions, design and development documentation, and technical files.
• Prepare documentation requested in support of internal audits; track what has been provided to auditors.
• Monitor a log of corrective and preventive action programs from point of identification to closure.
• Collaborate with regulatory affairs teams to ensure alignment of training programs with current regulatory expectations.
• Research, interpret, and stay abreast of current and emerging regulations and standards in the industry.

Basic Qualifications:

• Bachelor's degree or equivalent experience.
• 2 years of relevant experience.
• Microsoft Windows and Office proficient.
• Knowledge of FDA QSR, ISO 13485:2016, MDD, and CMDCAS.
• Good oral and written communication skills that demonstrate a professional demeanor and the ability to interact with others with discretion and tact.
• Good organizational, multi-tasking, and time management skills.
• Good collaboration skills applied successfully within a team as well as with other areas.
• Good Microsoft Excel skills.
• Good facilitation and project management skills.
• Good interpersonal skills; able to maintain solid rapport with team members as well as maintain professionalism with those outside of the department.
• Good data gathering, interviewing, and analytical/problem-solving skills.
• Good critical thinking and problem-solving skills.
• Ability to use original thinking to translate goals into the implementation of new ideas and design solutions.
• Self-motivated with the ability to manage projects to completion with oversight.
• Able to thrive in a fast-paced, deadline-driven environment.
• Good attention to detail.
• Demonstrated ability to influence, motivate, and mobilize team members and business partners.
• Good ability to develop and use engaging, informative, and compelling presentation methodologies.
• Good ability to handle sensitive information with discretion and tact.
• Good ability to establish rapport and gain the trust of others; effective at gaining consensus.
• Ability to work independently and in a team environment.
• Ability to understand federal, state, and international regulations and laws concerning medical devices.
• Good knowledge of systems administration.
• Good knowledge of industry standard compliance principles and best practices.
• Good understanding of core company products and technologies.
• Knowledge of FDA QSR, ISO 13485:2016, MDD, and CMDCAS.
• Up to 5% travel time required.