Invacare Corporation Elyria OH United States
4 weeks ago
Summary: The Manager of Regulatory Affairs is responsible for leading the overall regulatory affairs functions at Invacare. The position directs, coordinates and implements the preparation of all regulatory submissions, provides regulatory support to projects, handles annual facility registration and product licensing for FDA and Health Canada and manages the Corrections and Removals process... This position will serve as the principal regulatory affairs liaison in NA to regulatory agencies such as FDA, Health Canada, and notified bodies and will be responsible for advising Invacare management and other associates on the impact of new regulatory initiatives and changing regulations.
• Create and implement regulatory plans to obtain, maintain, and extend product clearances, registrations and regulatory compliance.
• Review, analyze and translate regulatory requirements into a workable deliverable for project teams, executive management decisions, etc.
• Develop the regulatory strategy for new products and ensure that modifications to existing products are in compliance with U.S. and Canadian regulations.
• Submit 510(k) applications to FDA when required and participate in the engineering change control process to provide guidance regarding engineering changes and potential for 510(k) or other regulatory impact.
• Participate in review of user manuals, marketing literature and other product labeling to ensure compliance with regulatory requirements.
• Develop and maintain documented regulatory procedures as required to assure consistent and compliant regulatory activities.
• Lead yearly project to review FURLS establishment and product listings for all Invacare facilities, including subsidiaries, to ensure all information is correct.
• Review all Medical Device Establishment Licenses (MDELs) for all Invacare sites, edit as needed and submit to Health Canada yearly.
• Maintain awareness of new products, government regulations and requirements and apply knowledge to Invacare
product development activities.
• Corporate Unique Device Identifier (UDI) Regulatory Affairs Lead .
• Maintain current knowledge of FDA and ISO 13485 regulation, guidance and standards applicable to company products.
• Interface directly with Notified Bodies and Regulatory Authorities during Surveillance Audit and review/approval of CE Technical Files.
• Act as the Regulatory liaison with global regulatory authorities on behalf of the organization to facilitate timely and favourable review of submissions and pre-submission activity.
• Participate in internal and external audits including the FDA relative to all activities and data associated with the Regulatory Affairs and Corrections & Removals processes.
• Ensure that all required training is identified for and completed by all direct reports.
• Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.
• Bachelor’s degree in Engineering, Science, Healthcare, Regulatory Affairs or equivalent degree. RAC certification preferred.
• 5-7 years in Quality Assurance and/or Regulatory Affairs within a medical device company.
• Knowledge and applicability of Quality Systems regulation (QSR), 21 CFR Part 820,; 21 CFR 803, 21CFR 806, and ISO13485.
• Experience with medical device recall coordination and execution preferred.
• Knowledge and understanding of appropriate sections of the FD&C Act, 21 CFR and Health Canada regulations.
• Ability to synthesize complex issues into clear and succinct written records.
• Successful submission of 510(k)s.
• Strong communication, analytical, organizational and management skills.
An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet
Elyria OH USA
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