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2 months ago
Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes. SUMMARY DESCRIPTION Under minimal supervision: Provides independent regulatory guidance to product development and life-cycle teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches, including submissions to transition devices from MDD to MDR compliance; guides conformance with applicable regulations in product development and life cycle activities, product/clinical/marketing claims, labeling content, and promotional materials; and helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development and life-cycle teams. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Utilizing advanced knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process, supports a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business. Provides regulatory input to management (with minimal supervision), cross-functional teams, and external partners. Works mostly independently to evaluate regulatory issues, contribute to, and implement regulatory strategies, and create and revise technical documentation for existing and new regulatory submissions. Prepares regulatory strategies with minimal supervision. Authors draft submissions and response to questions with minimal supervision. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. With minimal supervision, assists with the coordination, preparation, and maintenance of FDA 510(k), PMA and EU filings in accordance with USA FDA and EU submissions. Interacts with Regulatory Body personnel with minimal supervision. Actively assists and/or leads (with minimal supervision) in audits/investigations and certification reviews with internal auditors and external regulators. Supports communication with the Company's Notified Bodies and regulatory inquiries regarding regulatory issues/questions. Maintains Regulatory Affairs product files (e.g., EU Technical Documentation) to support compliance with regulatory requirements. Reviews promotional and advertising material for adherence to approved product claims and regulatory compliance. Works in partnership with cross functional teams, including Product Development, Manufacturing and QA/QC, to ensure overall compliance with US and EU directives and regulations. Coordinates rollouts of new product introduction and product changes with corporate and international regulatory teams. Coordinates with Regulatory Operations for updates to the Unique Device Identification system and to the FDA registration and device listing system. Reviews Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Bachelor's degree in science, Engineering, Regulatory Affairs, or other technically related field. Minimum of 8 years' experience in a regulatory role Excellent written, verbal communication and presentation skills Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives Consults with others to understand the benefits and risks associated with decision alternatives before making decisions Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables Makes decisions with guidance in ambiguous or unclear situations Demonstrated skills in contributing to multiple projects simultaneously. Established skill in objective thinking. Brings proposals for solutions to identified issues. Develops plans to meet pre-defined Regulatory goals. Responsible for tasks and intermediate submission components, based on templates. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Ability to communicate effectively in both informal and formal settings. Regulatory Affairs Certification (RAC) a plus and can be obtained on the job. It is estimated 5 - 15% travel may be required for this position. Ability to travel via car and/or airplane to domestic and international locations as needed.
