Sr Manager, Regulatory Affairs
Responsible for operational aspects of regulatory affairs for a defined product line/region, including leading, developing and executing regulatory strategies and filings for the defined responsibilities. Act as regulatory lead on project teams and as global regulatory advisor/leader. Manage a staff of regulatory professionals with responsibility for mentoring, developing, feedback and performance appraisals.
- Provide direct supervision of regulatory professionals.
- Plan and manage complex projects and prioritize regulatory workload across team members to meet functional objectives.
- Represent regulatory on assigned product teams and assure regulatory strategies world-wide align with objectives including coordinating directly with health authorities when required.
- Ensure project teams, deliverables and business objectives are aligned with RA strategy.
- Maintain appropriate communications within regulatory and across other functions at the project team level.
- Provide strategic and technical input for regulatory decisions.
- Respond to regulatory agency questions within defined timeline.
- Review and approve product labeling and advertising for compliance to applicable regulatory requirements.
- Support regulatory activities for government tenders.
- Establish systems to ensure post-market requirements (for example annual reports) are maintained, where applicable.
- Develop and maintain relationships with regulatory agencies.
- Monitor emerging issues and identify solutions.
- Mentor and train new team members in RA processes and procedures. May provide direct supervision of individuals.
- Strong technical, regulatory, and problem solving skills including an understanding of device and drug regulatory requirements, their foundation and submission processes.
- Excellent oral and written communication skills.
- Advanced interpersonal skills and a demonstrated ability to manage conflict situations.
- Management experience and a demonstrated record of responsible actions consistent with the values of the business.
- Proven Team player
- Proven effective collaboration with regulatory agencies.
- B.S/B.A. in a technical/scientific discipline with RAC certification or advanced degree preferred
- 8 years of experience in medical device industry including at least 6 in regulatory affairs with managerial experience.
- Successful track record in submission management including authoring, filing and receiving clearance for multiple 510k submissions with the US FDA, specifically on infusion devices.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
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, disabilities, or protected veteran status.
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.
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Job posted: 2021-03-03