Cardinal Health Regulatory Affairs Manager (US/EU) in Dublin, Ohio
The Regulatory Affairs Manager (US/EU) 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 International regulatory applications and filings including US FDA 510(k) submissions, Technical Files, Summary Technical Documents (STED) 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.
Principal Duties and Responsibilities:
- Prepare, assemble and submit regulatory submissions, such as 510(k) submissions, CE Mark Technical Files, Summary Technical Documents (STED), Device Design Dossiers and other international regulatory submissions in various countries within US and European regions.
- Provide input for regulatory requirements and regulatory strategies 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 ISO13485, Medical Device Regulation EU 2017/745, Medical Device Directive 93/42/EEC (and all applicable amendments), Personal Protective Equipment (PPE) Regulation2016/425, FDA's Quality Systems Regulations, GMP's, Canadian Medical Device Regulations; 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.
• BS Degree in engineering or science or a related scientific or technical field.
• Advanced degree and Regulatory Affairs Certification (RAC) is preferred.
• Affiliations with: Regulatory Affairs Professional Society, Advanced Medical Technology Association or American Society for Quality is a plus.
• Proven experience in receiving regulatory approval for medical device submissions.
• Minimum 5-7 years of experience in Regulatory Affairs with strong medical device product development and manufacturing experience covering several regulatory specialty areas of concern including device registrations, quality system requirements, new product development, design controls, etc.; experience in direct interaction with mainly international but also domestic Regulatory Agencies.
• Experience in analyzing and developing strategies for regulatory submissions and compliance issues including, but not limited to successful development and implementation of regulatory strategy for Class II or Class III (including de novo classification process) medical devices resulting in global regulatory product approvals.
• Knowledge of FDA's Quality Systems Regulations, GMP's, ISO13485, Medical Device Regulation EU 2017/745, Medical Device Directive 93/42/EEC (and all applicable amendments), Personal Protective Equipment (PPE) Regulation2016/425; ISO regulations/standards, including ISO 13485, 10993, 14971. Working knowledge of International Device/Biologics/Drug regulations with specific experience with Medical Device regulatory submissions.
• Ability to liaise, negotiate and interact with FDA and worldwide regulatory agencies; orchestrate meetings and teleconferences, document interactions between Novan and FDA.
• Experience managing, developing, organizing, and maintaining regulatory files.
• Demonstrated track record of successful regulatory submissions.
• Honest, flexible, dependable, self-motivated team player with the ability to work autonomously.
• Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills and ability to interact with all levels of management.
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
• Expertise in technical and operational aspects of regulatory affairs, combined with scientific understanding and strong project management.
• Must be process-oriented and have the ability to analyze, deconstruct, develop, and institute processes to support the business.
• Effectively prioritizes workload and manages time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced, interrupt-driven environment.
• Expertise in Microsoft Office applications is required, specifically Microsoft Word, Excel, Outlook, Project, PowerPoint, and SharePoint.
.Some travel may be required (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.