Job Description

Position Summary Responsible for domestic and/or international registration and renewal activities for Werfen‑labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance. Responsibilities Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post‑market modifications as part of design input. Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output. Prepare new product registration packages and technical files (e.g., CE Mark, 510(k)s, Canadian licenses). Provide support materials for Milan Regulatory for other country registrations. Assist with product renewal packages to maintain country registrations. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity. Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current standards. Maintain the Regulatory Database in SAP. Review marketing and sign promotional materials for signature by management (as appropriate). Review and sign labeling and Change Orders (as appropriate). Educate and train Werfen personnel on domestic and international country registration and labeling requirements. Other assignments related to RA/QA to support Werfen requirements and priorities. Qualifications Requires a Bachelor degree, preferably in life sciences or engineering. Familiarity with ISO 13485 and 14971 preferred. Two years minimum experience in the Medical Device Industry or other highly regulated environment. Additional Information International Mobility: No. Travel Requirements: Must be available to travel domestically and internationally as needed. Base Salary Range: $85,000 – $105,000 (annual). Compensation will depend on education, experience, skill set, and business needs. Benefits: Medical, dental and vision insurance; 401(k) plan with employer match; paid vacation and sick leave. Seniority level: Entry level Employment type: Full‑time Job function: Legal | Industry: Medical Equipment Manufacturing #J-18808-Ljbffr Werfen North America

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