ABBOTT LABORATORIES Regulatory Clinical Project Manager Salary in the United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Senior Scientific Clinical Evaluation Project Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Job Description

• The function of a Regulatory Clinical Project Manager (is to combine understanding of medical device regulations and guidelines, and product knowledge, to support  project management of Regulatory Affairs submissions 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, and EU MDR 2017/745.
•  This role acts as a liaison between the clinical evaluation group and regulatory affairs to interact cross-functionally with various personnel to ensure that the clinical documentation is completed as per regulatory requirements.    The role also requires the individual to monitor  other activities such as risk assessment and management, SSCP’s and PMCF plans and review of informational documents like the Instructions for Use. 
• This role is a cross franchise RA role that covers all of Abbott Vascular products
• Main Responsibilities:
• Compliance with applicable corporate and divisional policies and procedures.
• Support the cross functional teams in outlining deliverables, and the timelines of these documents.
• Facilitate communication and exchange of documents between stakeholders
• Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.

Requirements:

• Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., has understanding of research design, methodology, and statistics)
• A college degree (Bachelor’s) is required; post graduate degree (Masters or Doctorate) preferred.
• Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4.
• Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, including: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev.  4; ISO 14971; ISO 14155; ISO 13485.
• Effective written, verbal and presentation skills in the area of technical/clinical applications.
• Strong command of medical and surgical terminology.
• Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred.
• Project management and/or management of people experience.
• 3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device or pharmaceuticals industry
• Experience in electrophysiology or other active implantable devices preferred.
• Demonstrated ability to identify and adapt to shifting priorities and competing demands.
• Highly-developed interpersonal skills, and strong attention to detail.
• Audit experience (front room or back room) preferred.
• Certification is a plus (e.g., RAC and PMP).
• Able to travel as needed.