Senior Manager, Regulatory Affairs (MedTech)

• Own regulatory decisionmaking and strategy for assigned product lines, projects, regions, or regulatory initiatives involving significant complexity or regulatory risk
• Prepare, author, coordinate, or provide senior technical oversight for U.S. and/or international submissions (e.g., 510(k)/NDA Supplements, as applicable), involving complex, high-risk, or strategically significant regulatory issues, including responses to regulatory agency questions.
• Approve regulatory strategies developed by Managers and below.
• Represent Regulatory as the senior Regulatory Affairs lead on assigned product/project teams and ensure regulatory strategies worldwide align with business objectives.
• Maintain appropriate communications within Regulatory to align on technical regulatory positions and support escalation decisions, as well as across other functions at the project team level to ensure consistent execution across affected project teams.
• Provide strategic and technical input to support product development, project plans, and other business decisions, as needed.
• Monitor evolving regulatory requirements (including import/export requirements as applicable); assess potential impact on assigned products/projects or technologies and ensure compliance where applicable.
• Review and approve product labeling and advertising/promotional materials for compliance to applicable regulatory requirements.
• Support regulatory activities for government tenders/initiatives, including obtaining and maintaining professional certifications (if required).
• Ensure post-market regulatory compliance (e.g., annual reports, PADERs, PSURs, PMS/PMCF reports) are maintained, where applicable.
• Lead complex Health Authority interactions (e.g. meetings, negotiations, responses); develop and maintain effective relationships with regulatory agencies.
• Mentor and train other regulatory team members as appropriate.

Job Requirements

• Bachelor's Degree with 8+ years of experience in a regulatory function.
• Strong technical, regulatory, and problem-solving skills, including an understanding of device and/or drug regulatory requirements, their foundation and submission processes.
• Demonstrated experience with providing and executing complex regulatory strategies and/or managing novel regulatory challenges.
• Advanced interpersonal skills and a demonstrated ability to manage conflict situations and influence stakeholders.
• Proven effective collaboration with regulatory agencies.
• Experience with infusion systems, transfusion technologies, cellular therapies, or drugs preferred.
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.