Senior Clinical Evaluation Scientist/Project Manager at Abbott

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Understanding of scientific and research methodology
Knowledge of medical device regulations and guidelines (e.g., MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, EU MDR 2017/745)
Product and therapeutic area knowledge, specifically supporting Vascular product lines

Responsibilities

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
Ensure compliance with applicable corporate and divisional policies and procedures
Participate in and support internal and external audits and responses to audit findings as appropriate, including 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

Skills

Key technologies and capabilities for this role

Clinical EvaluationProject ManagementMedical DevicesHealthcare RegulationsScientific Research

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.

Is this a full-time position?

Yes, this is a full-time employment opportunity.

What are the main responsibilities of this role?

The role involves managing and providing oversight to CER Medical Writers for Clinical Evaluation Reports, setting project timelines, ensuring deliverables are met, and facilitating communication between stakeholders like Regulatory Affairs, R&D, and Quality Engineering.

What is the primary focus of this position?

The role supports Regulatory Affairs medical device submissions in the EU for CE Marking of new and existing Vascular product lines, in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance, and EU MDR 2017/745.

What does Abbott say about its company culture and work environment?

Abbott emphasizes doing work that matters, career growth, caring for yourself and family, being your true self, and living a full life; it's recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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