Senior Regulatory Affairs Specialist

18 Nov, 2020

Jobs

Senior Regulatory Affairs Specialist

Cantel
Plymouth, MN/Conroe, TX

Who we are

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 spirit 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.

About the role

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

  • Bachelor’s Degree
  • Minimum of 4 years of regulatory experience in medical devices
  • Experience in writing regulatory submissions

PREFERRED QUALIFICATIONS:

  • 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
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Job posted: 2020-11-18