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Clinical Evaluation, Principal Project Manager

Abbott Laboratories

This is a Contract position in New York, NY posted October 13, 2021.

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 109,000 colleagues serve people in more than 160 countries.

Our location in Santa Clara, CA has an opportunity for a Clinical Evaluation, Principal Project Manager .

The function of a Clinical Evaluation Project Manager is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support 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, and EU MDR 2017/745.

WHAT YOU’LL DO The Clinical Evaluation Project Manager will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events, and risk/benefit profile of a device or devices.

The Clinical Evaluation Project Manager will write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, Post-Market Surveillance Plans, Post-Market Clinical Follow-Up Plans and Reports, and Summary of Safety and Clinical Performance, or interact with vendor medical writers to create CER deliverables.

Moreover, the Clinical Evaluation Project Manager may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use.

The Clinical Evaluation Project Manager also may sit in on core team product development and respond to additional information requests from regulatory agencies.

Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical Engineering, Library Services, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as Medical Writers and Medical Reviewers).

Creates, manages, or participates in timelines of deliverables, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines EDUCATION AND EXPERIENCE YOU’LL BRING Required Bachelor’s is required Training and degree in science, engineering, or medical fields.

Scientific/research background (i.e., has understanding of research design, methodology, and statistics) 3 years of experience in clinical research, clinical engineering, risk management, post-market surveillance, or regulatory affairs in medical device or pharmaceuticals industry Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 is preferred.

Understanding of regulations, standards and guidelines related to medical devices, risk management, clinical studies, and quality systems, including: MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev.

4; ISO 14971; ISO 14155; ISO 13485 is preferred.

Able to travel as needed.

Preferred Post graduate degree (Masters or Doctorate) Effective written, verbal and presentation skills in technical/clinical applications.

Strong command of medical and surgical terminology.

Experience in cardiac devices preferred.

Project management and/or management of people experience is preferred.

Demonstrated ability to identify and adapt to shifting priorities and competing demands.

Highly developed interpersonal skills, and strong attention to detail.

Certification is a plus (e.g., RAC and PMP).

WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer:
•Training and career development, with onboarding programs for new employees and tuition assistance
•Financial security through competitive compensation, incentives, and retirement plans
•Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
•Paid time off
•401(k) retirement savings with a generous company match
•The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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