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 Regulatory Affairs Specialist (RAS) is responsible for developing regulatory strategy, preparing regulatory submissions, while supporting approval for Cantel products globally. This position translates regulatory requirements into project/product requirements, prepares regulatory submissions and negotiates approval with regulatory agencies. The Senior RAS supports both pre-market and post-market business goals, and mentors/coaches other regulatory staff members. #CB
What you will do
Prepares regulatory submissions and internal documentation for product changes and new product development.
Works with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies.
Resides on product development teams/project teams in providing regulatory feedback and guidance.
Reviews device labeling and advertising materials for compliance to applicable regulations and submissions.
Provides support for currently marketed products by reviewing product changes and documentation and assessing the regulatory impact of those changes.
Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
Acts as company representative, developing and maintaining positive relationships with regulatory authorities.
Maintains proficiency in government regulations and guidances.
Develops and maintains procedures to ensure compliance and support business goals.
What we are looking for
Minimum of 4 years of regulatory experience in medical devices
Experience in writing regulatory submissions
Master’s degree in scientific, engineering or technical discipline
Experience authoring U.S. 510Ks
Able to compile data and summarize results
Direct interactions with regulatory authorities
Ability to effectively manage multiple projects and priorities
Internal Number: 2020-8849
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.