Abbott · 1 month ago
Clinical Evaluation, Project Manager - Clinical Scientist
United States - Minnesota - Maple Grove
Full-time
Onsite
Senior Level
$87K/yr - $173K/yr
7+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Clinical Evaluation Project Manager to support Regulatory Affairs submissions for CE Marking of new medical devices and maintain CE Mark for existing devices, ensuring compliance with European regulations. The role involves managing medical writers, overseeing clinical evaluation documents, and providing strategic guidance on regulatory requirements.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Manage medical writers’ efforts in writing and editing of scientific content of deliverables, and the timelines of these documents
Creates, manages, or participates in timelines of deliverables by using appropriate project management tools
Clearly and timely communicates the timelines, project risks, and risk mitigation strategies with cross functional teams and medical writers
Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice
Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables
Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions
Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers)
Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation to new product development teams and sustaining teams
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
Function independently as a decision-maker on CER-related regulatory issues and must assure that deadlines are met
Execute projects within budgetary guidelines
Qualification
Required
Associates Degree (± 13 years)
Minimum 7 years
Preferred
A college degree (Bachelor's); in the life sciences (nursing, medicine, biomedical engineering)
Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions
3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device
Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, MDD 93/42/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
Project management and/or management of people experience
Demonstrated ability to identify and adapt to shifting priorities and competing demands
Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time
Post graduate degree (Masters or Doctorate) preferred in the life sciences (nursing, medicine, biomedical engineering)
Experience in structural heart / structural intervention devices
Certification is a plus (e.g., RAC and PMP)
MD / PhD/RN/Pharm D with good written skills
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
H1B Sponsorship
Abbott has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
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