SUMMARY: The Senior Manager of Regulatory Affairs and Compliance is responsible for leading the overall pre-market and post-market regulatory affairs and regulatory compliance functions at Invacare. The position directs, coordinates and implements the preparation of all regulatory submissions, provides regulatory support to projects, coordinates inspection and audit readiness, inspection and audit management, and manages internal regulatory compliance audits for the purpose of confirming compliance and identifying opportunities for improvement. This position will serve as the principal regulatory affairs liaison in NA to regulatory agencies such as FDA and notified bodies and will be responsible for advising Invacare management and other associates on the impact of new regulatory initiatives and changing regulations as they pertain to the Company’s R&D and commercial products.
ESSENTIAL FUNCTIONS:
- Create and implement regulatory plans to obtain, maintain, and extend product clearances, registrations and regulatory compliance.
- Work closely with other function leaders and across project teams to ensure that all activities are conducted in compliance with relevant laws and regulations.
- Review, analyze and translate regulatory requirements into a workable deliverable for project teams, executive management decisions, etc.
- Anticipate the impact of future regulatory changes on the business and take appropriate actions.
- Work closely with senior management on regulatory issues and be proactive in making the Company aware of impending product or regulatory issues that present a risk to the business.
- Make recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
- Develop and maintain relationships inside and outside of Invacare with regulatory, governmental and notified body organizations and agencies.
- Manages corrections and removals process to determine the need, and when necessary execution, of field actions
- Provide leadership and coordinate presentation of information by cross-functional Invacare associates during audits including FDA inspections and ISO audits.
- Drive regulatory process to ensure timely filing and approval or clearance of new products in accordance with business objectives.
- Provide leadership in all areas of regulatory submissions including coordinating regulatory workflow, reviewing technical documents, developing and tracking submissions timelines and providing leadership on the preparation of regulatory submissions to ensure compliance with FDA regulations and guidance.
- Manage the Regulatory Affairs and Compliance budget.
- Develop, manage, and ensure that all required training is completed by direct reports.
- Evaluate staffing needs and costs; identifies, hires and promotes individuals with the right skills and competencies necessary to achieve superior results.
- Develop a team environment that values inclusion and uses various individual’s strengths to the benefit of the team.
- Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.
Required Skills
Required Experience