Senior Project Manager, Clinical Evaluation
Abbott
full-time
Posted on:
Location Type: Office
Location: Santa Clara • California • Minnesota • United States
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Job Level
Tech Stack
About the role
- Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverables and project timelines and ensure timelines are met.
- Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
- Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents.
- Draft and/or lead the development of regulatory responses for Notified Body and regulators’ questions upon review of submissions.
- Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
- Compliance with applicable corporate and divisional policies and procedures.
- Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
- Develop and update new policies, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them.
- Function independently as a decision-maker on CER-related regulatory issues.
Requirements
- Bachelors Degree (± 16 years) Preferably in Life Sciences OR An equivalent combination of education and work experience
- Minimum 5 years Medical devices, clinical research experience, or related industry
- Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment
- Prefer GCP audit experience
- Fluent in English, any additional major language is a preferred asset
- Excellent Communicator
- Computer Literate.
- Preferred Master’s Degree, RN, PharmD, PhD, or MD preferred.
- Thorough understanding of the EU MDR 2017/745, MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidance on clinical evaluations, SSCP, PMCF plans and reports, and other international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems.
- Project management experience.
- Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
- Strong command of medical and surgical terminology.
- Demonstrated ability to identify and adapt to shifting priorities and competing demands.
- Proven ability to deliver high-quality work within tight timelines.
- Highly-developed interpersonal skills, and strong attention to detail.
- Able to travel as needed.
Benefits
- No specified benefits mentioned
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Evaluation ReportsRegulatory responsesGCP auditProject managementMedical devicesClinical researchQuality systemsRoot cause analysisPreventive actionsCorrective actions
Soft Skills
Excellent communicatorWritten communicationVerbal communicationPresentation skillsInterpersonal skillsAttention to detailAdaptabilityTime managementDecision-makingTeam training
Certifications
Bachelor's DegreeMaster's DegreeRNPharmDPhDMD