Overview In this role you will lead the development and maintenance of clinical evaluation documentation and manage regulatory submissions for EU CE marking. You will work within Abbott Vascular to translate clinical evidence and risk data into robust regulatory artifacts, collaborating with cross-functional teams. You will steer timelines, communicate risks and mitigation strategies, and support audits and regulatory responses. This position offers impact on device regulation and patient safety in a global healthcare leader.
Compensation / Benefits- HIP PPO medical plan eligibility
- retirement savings with high employer contribution
- tuition reimbursement and education benefits
- career development with international company
- diversity and recognition as a great place to work
- health and wellness programs
Responsibilities- Create and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCPs; draft regulatory responses
- Identify and synthesize clinical evidence from investigations, literature, and post-market data
- Plan and track deliverables using project management tools; manage timelines and risks
- Provide strategic input on regulatory requirements for clinical data in product development
- Lead/participate in responses to Notified Body questions and regulatory inquiries
- Coordinate information flow among internal stakeholders and external vendors
- Support audits and root-cause analysis activities related to quality and regulatory findings
- Operate as a decision-maker on CER-related regulatory issues and manage budget adherence
Key requirements- Bachelor degree; science/engineering/medical field background
- Thorough understanding of EU MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev 4, and related guidelines
- Project management experience
- Excellent written, verbal, and presentation skills in clinical/technical applications
- Strong medical and surgical terminology knowledge
- Ability to adapt to shifting priorities and tight timelines
- Travel up to
- Excellent communication and cross-functional collaboration
- Attention to detail and strong analytical thinking
- Proactive risk assessment and mitigation mindset
- Clinical evaluation planning and reporting (CER)
- Regulatory submissions and strategy for medical devices
- Knowledge of MEDDEV 2.7/1 Rev 3/4; MDD/AIMDD; EU MDR 2017/745
