ITS has a client in the Toledo, OH area seeking a Quality/Regulatory Affairs Manager. This is a direct hire role with full benefits including 401k.
Summary of Position:
The Quality/Regulatory Affairs Manager ensures regulatory compliance for Class I and II medical devices per FDA, EU MDR, and ISO 13485 standards. This role acts as the liaison between the organization and regulatory agencies, managing product registrations and ensuring product conformity with quality system requirements. Key duties include overseeing regulatory submissions, supporting EU MDR documentation, managing customer complaints and CAPAs, and supervising supplier quality activities. The manager also provides regulatory expertise to cross-functional teams. Additionally, they serve as the Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC) during audits.
Duties and Responsibilities:
• Manages Regulatory compliance activities associated with Class I and II Medical devices per FDA, MDR, and ISO 13485 requirements.
• Act as Quality and Regulatory liaison between the organization and customers/agencies.
• Interprets and communicates international regulatory product requirements and as applicable submits and maintains product registrations.
• Identifies and communicates changes to standards and regulatory requirements.
• Ensures the conformity of products is appropriately checked in accordance with quality system requirements prior to the receipt of raw materials and release of finished goods.
• Reviews and approves validation documentation, product specifications, standard operating procedures and any revisions to these documents ensuring they are conducted in accordance with applicable standards.
• Ensures label claims and content of materials meets statutory and regulatory requirements.
• Troubleshoots process problems, define root cause, coordinate implementation of corrective actions and verify effectiveness.
• Oversees regulatory submissions for entry into new markets or addition of new devices to current markets.
• Supports EU MDR Technical Documentation activities including evaluating Clinical Evaluation Reports/Post Market Surveillance Reports.
• Supervises the customer complaint handling process to ensure timely evaluations for potential regulatory reporting
• Oversees supplier quality activities to ensure that vendors are adequately approved, monitored, and issued corrective actions to resolve issues.
• Provides regulatory and technical expertise to cross-functional teams
• Manages the CAPA process, collaborating with other departments to ensure effective root cause analyses and the development of appropriate long-term solutions.
• Oversees the quality control functions which may include assisting with sampling plans, supplier development, and quality training.
• Directs the activities for Quality Control, Quality Assurance, and Regulatory Affairs staff.
• Acts as the Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC) for the organization.
Qualifications, Training, and Experience:
• Minimum of a Bachelor’s degree.
• Minimum of 2 years managing direct reports.
• Minimum of 5 years in a regulated environment in one of the following functions: Quality Control/Assurance or Regulatory, preferably in an environment with onsite manufacturing of medical devices.
• Strong international regulatory knowledge and acumen.
• Knowledge of standards and requirements related to FDA/GMP compliance.
• Knowledge of standards and requirements related to ISO 13485 compliance.
• Experience with FDA and EU MDR submissions, as well as other international medical device regulations and submissions.
