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.
The Senior Clinical Affairs Specialist is responsible for developing clinical evidence strategies and authoring clinical evidence documents for Cantel businesses. This position translates data from a variety of sourcesin creating medical device clinical evidence, which is used in support of regulatory applications andbusiness objectives. The Senior Clinical Affairs Specialist helps support new product developmentactivities as well as maintaining currently marketed devices. #CB
What you will do
Authors Clinical Evaluation Plans and Reports, Clinical Literature Search Reports, Post Market Clinical Follow-up Plans and Reports.
Evaluates and generates clinical evidence from a variety of sources; literature, post-market surveillance, instructions for use, and risk documentation.
Collaborates with cross-functional colleagues in planning and supporting clinical evidence related projects and processes.
Identifies appropriate sources of relevant data, interprets, evaluates and incorporates into clinical evaluation documents.
Reviews risk management files, instructions for use, clinical evidence documents, training materials, regulatory submissions, and promotional collateral to ensure alignment of risk information.
Works with cross-functional peers to resolve technical issues and questions from regulatory agencies.
Updates and remediates, as necessary, historical clinical documentation to meet current standards.
Participates in audit preparation activities, audit room support, and post-audit deliverables.
Develops and designs clinical trial designs to support post-market, and where applicable, pre-market requirements.
Maintains proficiency in government regulations and guidances.
Develops and maintains procedures to ensure compliance and support business goals.
What we are looking for
5 years of clinical affairs experience
Experience in writing clinical evidence documents
Medical or Nursing Degree
Strong attention to detail
Proficient knowledge of medical terminology
Able to compile data and summarize results
Experience in pre-market and post-market clinical trial design
Internal Number: 2020-8243
At Cantel, preventing infection is our business. As a leading provider of infection prevention products and services in the healthcare market, we are dedicated to delivering high-quality, innovative solutions that improve outcomes and help save lives. We accomplish this mission by delivering our products through the following operating units:
Medical: Endoscopy procedure disposables include single-use valves and irrigation tubing. The medical device reprocessing systems, disinfectants, detergents we manufacture and distribute are used to disinfect high-level endoscopes.
Life Sciences: Water purification systems for dialysis facilities. We work with leading dialysis caregivers, delivering hemodialysis dialyzers and reprocessing systems, as well as sterilants and filtration products.
Dental: Single-use, infection prevention products used primarily in the dental market (face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants).
Cantel employees are inspired to improve the lives of patients, caregivers and healthcare providers. If you are looking for a company driven by an entrepreneurial sp...irit and have the passion to shape the future of infection prevention, we want to meet you. Join us and see why people love working here.