Senior Project Manager, Clinical Evaluation

Abbott Laboratories • Maple Grove, MN

10d • $90,000 - $180,000

About The Position

The primary function of a SENIOR CLINICAL EVALUATION SCIENTIST/PROJECT MANAGER is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745. This role will support the Vascular product lines.

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.
• Specific requirements: Fluent in English, any additional major language is a preferred asset; Excellent Communicator; Computer Literate.

Nice To Haves

• 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 (<10%).
• 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
• 3-5+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.
• Knowledge of Cardiovascular devices and technologies.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees