Senior Regulatory Affairs Specialist

Kelly, in partnership with Johnson & Johnson, is hiring a Senior Regulatory Affairs SpecialistDescription:Prepare regulatory documentation to support the market distribution of new and modified medical devices (510(k)/NTF) in the US, Canada, and EU. Support global registrations in the rest of the world. Review device labeling, including all graphic materials. Prepare export certificates, medical device listings, and annual establishment registrations for submission to the U.S. Food and Drug Administration (FDA). Assist the group in maintaining regulatory databases for all products. Provide support to the Regulatory Manager for special projects as needed.Key Responsibilities include, but are not limited to:Compile, prepare, review, and submit regulatory submissions to regulatory authorities.Monitor and submit applicable reports and ensure appropriate responses are provided to regulatory authorities for division orthopedic devices.Interface with Product Development to obtain necessary information for regulatory submissions.Review and approve Custom Device Requests.Review and approve Engineering Change Requests/Notices.Prepare export certificates, medical device listings, and annual establishment registrations.Respond to requests for information on import detentions.Maintain regulatory database, ensuring ongoing updates with regulatory information.Assist in developing and implementing SOPs and systems to track and manage product-associated events.Assist in developing regulatory strategy and update strategy based upon regulatory changes.Provide regulatory input to product lifecycle planning.Evaluate regulatory impact on proposed products.Understand, investigate, and evaluate regulatory history, background of class, disease/therapeutic/diagnostic context to assess regulatory implications for approval.Determine and communicate submission and approval requirements.Begin to participate in risk-benefit analysis for regulatory compliance.Submit and review change controls to determine the level of change and consequent submission requirements.Continually revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.Provide training for staff on current and new regulatory requirements.Communicate regulatory agency and industry positions within the regulatory department.Problem-solve with and advise internal stakeholders on regulatory issues.Identify standards for the organization’s products.Participate in professional associations, industry/trade groups (local/regional/international), and appropriate standards organizations.Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.Diligently participate in compliance program-related activities as denoted by your supervisor or the Chief Compliance Officer.Review and approve labeling: device labels, brochures, technique guides, bulletins, updates, etc.Responsible for communicating business-related issues or opportunities to the next management level.Responsible for following all Company guidelines related to Health, Safety, and Environmental practices as applicable.For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so a reavailable and in good condition, if applicable.Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.Perform other duties as assigned as needed.Required Skills and Experience:Bachelor’s degree.Four to six years of regulatory experience in medical devices or relevant medical device industry experience.Knowledge of clinical research, clinical operations, nonclinical, quality, and regulatory requirements, and GxPs (GCPs, GLPs, GMPs).General knowledge of submission types and requirements.Ability to apply risk-benefit analysis techniques.Ability to handle multiple tasks and be detail-oriented.Excellent written and oral communication skills.Excellent organizational skills.Preferred Skills and Experiece:Advanced degree.Experience preparing 510(k) submissions and CE marking regulatory documentation.