What QRA Management contributes to Cardinal Health
QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function.
The Regulatory Affairs Manager will be responsible for managing regulatory affairs for Brazil. Responsibilities will include the development of most optimal regulatory strategies for medical device product registrations, preparation and submission of regulatory submissions files, assessment of changes for impact on current regulatory filings and registrations. The Regulatory Affairs Manager will act as a primary interface with regulatory bodies, consultants, and internal team members on regulatory affairs matters related to Colombia. This position is expected to provide regulatory leadership on project teams, lead development of the medical device regulatory strategy, and support regulatory tactics and operations.
What is expected from you and others in this role?
Prepare, assemble and submit regulatory submissions, such as Summary Technical Documents, Device Design Dossiers and other regulatory submissions.
Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submissions and approval.
Determine product classifications, regulatory filing strategies and submission types. Participate in medical device product development teams and develop overall regulatory strategy that delivers on project costs, timeline and regulatory bodies approval.
Ensure that project work proceeds according to agreed deadlines and maintain status records.
Responsible for performing all duties in compliance with ISO13485, EU Directives, FDA’s Quality Systems Regulations and GMP's; and other applicable international regulatory requirements. The manager will also compile and/or review all submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
Responsible for regulatory related design and development activities, including providing input on materials, testing, validations, and other outputs to demonstrate compliance with regulatory requirements.
Participate in root cause analysis, corrective and preventive actions for product and process issues, including internal and external audits, as necessary. Maintain regulatory affairs documents and systems including the Regulatory Product Submissions and Regulatory Tracking database.
Evaluate changes to controlled documents for impact on submissions and filing requirements, including providing a technical review of and approval for proposed changes and supporting documentation. Make recommendations for regulatory and compliance operating procedures and may be responsible for creating and reviewing SOPs as needed.
Provide input on and review of protocols and reports for: design verification and validation for material, process and facilities changes, assay/method validation, shelf life, clinical and non-clinical studies, material qualification and safety testing in support of product submissions and marketing collateral.
Determine governmental regulations affecting Company processes and assure the processes are complete and accurate to ensure company compliance. Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Act as Sanitary Responsible / Technical Representative for Company with regulatory agencies, as well as with other internal functional departments for new product submission strategy. Participate in regulatory agency inspections such as Pre-Approval Inspections, Quality System Inspections, and cGMP inspections, as necessary.
Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
The Regulatory Affairs Manager shall adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description
Perform other duties as assigned.
Bachelor’s Degree in a scientific discipline, preferably Pharmacy sciences.
Advance proficiency in – English and Spanish (written, verbal and presentation)
5+ years of experience in managing Regulatory Affairs for medical devices
Medical Device Class III experience
Proven experience with preparation of regulatory submissions and demonstrated track record of successful regulatory approvals for medical devices and/or combination products
Proven experience with new product development, design controls, quality management systems.
Demonstrated track record of successful negotiations with regulatory bodies with respect to product submissions and regulatory strategies
Knowledge of FDA's Quality Systems Regulations, GMP's, ISO13485 (QA)
Expertise in technical and operational aspects of regulatory affairs, combined with scientific understanding and strong project management.
Expertise in Microsoft Office applications is required, specifically Microsoft Word, Excel, Outlook, Project, PowerPoint.
High level of understanding of Combination products regulations
Regulatory Affairs Certification
Advance degree or certifications
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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