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.
Prepare, and submit international regulatory submissions (510(k), CE Mark Technical Files, Summary Technical Documents (STED), Device Design Dossiers, etc.) across US/EU
Provide input for regulatory requirements and regulatory strategies on product development to ensure timely submission and approval.
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) Regulation 2016/425, FDA's Quality Systems Regulations, GMP's, Canadian Medical Device Regulations; and other international regulatory requirements.
Compile and 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.
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
Participate in regulatory agency inspections regarding Pre-Approval , Quality System and cGMP
Lead negotiations, orchestrate meetings and document interactions between Novan and FDA
Bachelor's Degree in Engineering or a related technical field, or equivalent work experience, required
Masters Degree or Regulatory Affairs Certification (RAC), strongly preferred
5+ years of experience in Regulatory Affairs
Working knowledge of regulatory approval for medical device submissions (510K, Design Dossier, STED, etc.), required
Working experience of Unique Device Identifier (UDI) regulations, strongly preferred
Working knowledge of FDA Quality Systems Regulations, GMP's, ISO 13485, Medical Device Regulation EU 2017/745, Medical Device Directive 93/42/EEC, Personal Protective Equipment (PPE) Regulation 2016/425; ISO regulations/standards, including ISO 13485, 10993, 14971, strongly preferred
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 medical devices resulting in global regulatory product approvals, strongly preferred
Experience with medical device product development; regulatory manufacturing device registrations, quality system , new product development, design controls
Working knowledge of International Device/Biologics/Drug regulations with specific experience with Medical Device regulatory submissions
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.
Travel 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.