IVDR Project / Product Manager (Onsite – Lake Forest, IL) Position Available In Wake, North Carolina

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. This role is 100% onsite (Lake Forest, IL), full-time and will last through the end of 2025 (potentially into 2026). Drive IVDR program through management of cross functional teams. Conduct real time tracking of assays transitioning from IVDD to IVDR compliance. Monitor applications under Notified Body regulatory review and communicate progress to internal stakeholders. Monitor assay transition by third-party manufacturers and communicate progress to internal stakeholders. Coordinate with manufacturing sites and third party manufacturers to provide documentation to internal Abbott country affiliates to facilitate timely completion of regulatory submissions and regulatory body approvals. Track applications under regulatory body review and communicate application progress to internal stakeholders. Manage product launch and distribution cross-functional activities. #LI-EB3 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. •ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.•Don’t see an open opportunity that matches your qualifications? Join our talent community to stay connected for potential future opportunities. Upload your resume/CV and contact details for our Talent Acquisition team to review and match for potential future opportunities. While you are here, sign up for Job Alerts to receive alerts of future opportunities that match your selected interests. To change the language, click on “English” at the top right corner of the screen and select your preferred language. If you are already signed in, click the cloud icon and go to Change Language. ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (domain@propharmagroup.com). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud. Are you currently a ProPharma colleague? To be considered for an opportunity, please apply through the Jobs Hub in Workday.