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Regulatory Affairs Specialist II - Medical Devices

Location: 

Allendale, NJ, US

Req ID:  400
Job Type: 

Edgewell Personal Care is one of the world's largest manufacturers and marketers of personal care products in the wet shave, sun and skin care, feminine care and infant care categories. We are a global team of 6,000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

 

Our brands include Schick and Wilkinson Sword razors and blades, Playtex baby products including Diaper Genie, Playtex Gentle Glide and Sport, and o.b. tampons, Carefree and Stayfree pads and liners, Banana Boat and Hawaiian Tropic Sun care, Bull Dog and Jack Black Men's skin care and grooming products, Edge and Skintimate shaving gels, and Wet Ones wipes.

Position Summary:

With modest supervision, this Regulatory Specialist II position provides regulatory support to the successful commercialization of all personal care product categories, with emphasis on feminine hygiene products in global markets. These products fall under the FDA's category of Class I and Class II medical devices.

 

Accountabilities

  • Provide day-to-day regulatory support for new product development and commercialization projects.
  • Review and approve  raw materials and other product design criteria.
  • Prepare regulatory submissions to health authorities.
  • Maintain up-to-date product registrations, including registration expirations, discontinuances or product changes.
  • Work with manager to determine product registration plans and strategies.
  • Review and provide Regulatory input to development contracts for minor device adjustments, line extensions or package changes.
  • Review product changes to determine impact to existing labeling or registration; provide Regulatory input to change control requests.
  • Review and approve artwork to meet regulatory requirements.
  • Collaborate with Marketing, R&D, Program Management, Operations and other cross-functional team members to meet required deadlines.
  • Provide technical Regulatory representation on cross-functional teams, with emphasis on product launch planning and execution.
  • Research and monitor changes in standards and regulations that may impact to the business.
  • Work with global regulatory staff to help ensure regional regulatory requirements are met.
  • Author Standard Operating Procedures for routine Regulatory transactions and work processes.
  • Track, identify, measure and communicate trends in Regulatory transactions and initiatives.

 

Required Education, Skills and Experience

  • Bachelor's Degree, preferably in biology, chemistry, engineering or material science discipline, plus 4-6 years of Regulatory Affairs experience.
  • Good understanding of FDA and Health Canada regulations on medical devices as they apply throughout the product lifecycle.
  • Experience with medical device product registration and licensing is required.
  • RAC certification is a plus.
  • Above average computer skills. Proficiency with Word, Excel, Access/databases e-mail and internet applications.
  • Excellent verbal / written communication and interpersonal skills.
  • Ability to interface with internal and external contacts at all levels.
  • Strong attention to detail.
  • Good record-keeping skills.
  • Excellent organizational, prioritization and follow-up skills.
  • Ability to handle multiple tasks / projects simultaneously.
  • Self-starter with ability to think and act independently and to make sound decisions.
  • Demonstrated ability to complete projects on time.
  • Good analytical and problem-solving skills.

 

Work Environment

  • Some travel is required.

 

Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.

 

 #LI-DF1

*CB*


Nearest Major Market: New Jersey

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