Abbott is a global healthcare leader that helps people live more fully at all stages of life. As a Principal International Regulatory Product Specialist, you will contribute regulatory input to product and process change plans, lead cross-functional working sessions, and provide regulatory input to product lifecycle planning. You will also assist in SOP development and review, provide regulatory input for product recalls and recall communications, and support knowledge sharing by facilitating training and providing guidance to peers on new/updated requirements.
Requirements
- Bachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, engineering, scientific affairs, operations, or related area.
- Experience collaborating across QA, R&D, Clinical, Labeling, and Operations; may consider strong cross-functional experience with demonstrable regulatory change leadership
- Advanced level degree
- Experience with EU and other international medical device / drugs / pharma regulations and submissions.
- Experience with design controls in medical devices, IVDR, Pharma industries
- Proficient with Excel and PowerPoint and presenting information to leadership; experience with Veeva Vault and dashboarding/automation (e.g., reminders/escalations) is a plus.
- Previous experience working in a highly matrixed and geographically diverse business environment
Benefits
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
