The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Provides project management and display a proactive approach to plan, prepare and execute one (or more) high quality clinical project(s) to ensure safety and effectiveness of BALT and BALT’s affiliates products. Directly manages contractors and Clinical Research Organizations (CRO) resources project team members toward completion of deliverables in a timely fashion within agreed project timelines and budget. Interfaces with data management, biostatistics, clinical research associates, trial coordinators, field clinical monitors, and acts as BALT liaison with site investigators and clinical site staff.
Responsible and accountable for the management and coordination of one or more clinical trial(s).
Responsible for ensuring the trial is “audit ready” at any point in time (project team training records, central files, system validation, etc.).
Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
Responsible for effective communication within the Clinical Project Team and with functional management.
Manages the project(s) within the approved budgets and timelines.
Directly in charge of the selection, contracting, coordination and management of the CROs contracted for a given project.
Responsible for writing and/or supervising the CROs for the development of clinical project deliverables such as protocol, final study report, study manuals, study tools and operational plans.
Prepares investigational site lists and participates in reviewing and approving investigational sites.
Directs forecasting of devices necessary for project in collaboration with supply-chain.
Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team.
Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
Prepares and presents the status of the clinical project(s) to the Clinical Management.
Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.
Demonstrates thorough knowledge in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BALT SOPs and policies.
Is also assigned to other non-trial related activities such as process and procedure teams.
Analytical - Ability to analyze complex or diverse information; collects and researches data; uses results, intuition and experience to synthesize product specific direction
Design - Generates creative solutions; demonstrates attention to detail
Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions. Ability to develop good interpersonal relationships with medical professionals. Good presentation skills.
Written Communication - Writes clearly and informatively; presents numerical data effectively; able to read and interpret medical, scientific and engineering literature
Organizational Support - Supports organization's goals and values
Adaptability & Dependability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments;
Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. Independently motivated.
Demonstrated ability to manage multiple global complex clinical projects
Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical, Pharmacy or Veterinary Sciences) preferred.5-7 years’ experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials.
Internal Number: 002
About Balt USA
For the past 40 years, Balt’s focus has been to collaborate with the Neurointerventional community to address clinical challenges and improve patient care by providing technical innovations supporting the development of the field, including:
The First Flow Directed Microcatheter
The First Detachable Tip Microcatheter
The First intracranial Braided Stent
The First Flow Diverter
Founded in 1977, Balt’s excellence and DNA originates from its lineage of strong leadership; originating with Balt’s founder, Léopold Plowiecki, then his son Nicolas Plowiecki, and continuing today with the CEO of Balt, Pascal Girin.
As Balt is entering a new and exciting expansion phase combining the well-established Balt family of products with a truly global reach, Balt will continue to design, develop, manufacture and commercialize the most complete suite of neuro innovative products developed through inspired by ongoing collaboration with the Neurointerventional community.