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LeMaitre Vascular Clinical Project Manager in Burlington, Massachusetts

LeMaitre Vascular has recently been identified as the 16th largest medical device company in Massachusetts by the Boston Business Journal and named to Deloitte’s Technology Fast 500 and New England Technology Fast 50. LeMaitre Vascular is a leading global provider of innovative medical devices for the treatment of peripheral vascular disease. We develop, manufacture and market disposable and implantable vascular devices to address the needs of vascular surgeons and interventionalists. The Company is listed on NASDAQ.

Candidate will be responsible for developing and implementing Post Market Clinical Follow-up (PMCF) plans and studies for LeMaitre’s products to ensure continued compliance with the European Medical Device Regulation (MDR).

Responsibilities:

Candidate will be responsible for developing and implementing Post Market Clinical Follow-up (PMCF) plans and studies for LeMaitre’s products to ensure continued compliance with the European Medical Device Regulation (MDR).

The Project Manager, Clinical Affairs will report to the Clinical Project Manager, Clinical, Regulatory and Quality Affairs and have the following primary responsibilities:

  • Responsible for the development of the PMCF Plans;

  • Development and maintenance of Clinical Evaluation Reports;

  • Identify, recruit, and coordinate with the clinicians to implement PMCF studies;

  • Lead and/or support the drafting of the PMCF report;

  • Interact with the Notified Body related to PMCF studies;

  • Review regulations and guidance to keep apprised of new regulatory developments, particularly in the post market clinical requirements;

  • Manage the budget and expenses related to PMCF studies;

  • Other responsibilities assigned by the management.

Qualifications:

  • Bachelor's degree from four-year college or university

  • At least 5 years related experience in a Clinical Affairs role

  • Working experience in Cardiovascular device field is strongly preferred

  • Basic understanding of the biostatistics

  • Basic understanding of Medical Device Regulatory and Quality affairs

  • Experience and training of project management

  • Able to travel to the clinical sites (national and international, up to 30%)

  • Ability to read, analyze, and interpret general, professional journals, technical procedures, and regulations.

  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the regulators.

  • Fluent in English

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.

ID: 2021-1713

External Company URL: lemaitre.com

Street: 32 Third Avenue

Post End Date: 9/30/2021

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