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The Regulatory Affairs Manager will be responsible for managing and regulatory affairs for medical devices, including compliance with medical device quality system regulations. The individual will develop the regulatory strategy for medical devices by interfacing with regulatory bodies, consultants, and internal team members. This position will prepare and submit domestic and International regulatory applications and filings including 510(k)s, Technical Files, Summary Technical Documents and Design Dossier submissions, as well as prepare internal regulatory file documentation. 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. 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.
What is expected of you and others at this level
- Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
- Participates in the development policies and procedures to achieve specific goals
- Recommends new practices, processes, metrics, or models
- Works on or may lead complex projects of large scope
- Projects may have significant and long-term impact
- Provides solutions which may set precedent
- Independently determines method for completion of new projects
- Receives guidance on overall project objectives
- Acts as a mentor to less experienced colleagues
Principle duties and responsibilities
- Prepare, assemble and submit regulatory submissions, 510(k) submissions and international regulatory submissions in various countries.
- Prepares regulatory strategies for medical devices products to determine regulatory pathways to market including FDA Letter to File"" rationales for devices. Provide input for regulatory requirements in interdepartmental meetings on product development to ensure timely submission and approval. Determine 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 FDA approval. Ensure that project work proceeds according to agreed deadlines and maintain status records.
- Responsible for performing all duties in compliance with FDA's Quality Systems Regulations, GMP's, ISO13485; and other international regulatory requirements. The manager will also compile and/or review all regulatory agency 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 liaison 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.
- Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
- Perform other duties as assigned.
- 5-8 years of experience in managing Regulatory Affairs for medical devices is required.
- Bachelor’s Degree in a scientific discipline or a related field required
- Experience working with FDA and International regulations.
- Experience filing submissions for medical devices in the US and International markets, i.e. 510(k)s, Technical Files, Summary Technical Documents (STED).
- Experience managing functional groups in the development of relevant data to complete a regulatory submission
- Experience with submissions for software driven medical devices is preferred
- Experience in the areas of drugs, biologics and combination products is preferred
- Demonstrated communication and presentation skills
- Demonstrated attention to detail and organizational skills
- Regulatory Affairs Certification (US or International) is preferred
Up to 15%""
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.