Regulatory Affairs Manager, CAN/LA/SA

Kaz,Inc., is a fast-growing, global manufacturer and marketer of durable health care and home environment products principally under the Vicks, Braun and Honeywell brand names. Kaz is the leader in the humidification, thermometer and hot/cold therapy categories and also participates in the air purification, fan, heater and lawn & garden categories. Kaz’ products are largely distributed through mass merchandisers and drug stores. For more information on Kaz, visit http://www.kaz.com/.

Kaz is currently seeking a Regulatory affairs manager to work with the VP of Regulatory Affairs and Regional Managers to support the preparation and submission requirements for Canada, Latin America and South America.  This position will also support the submission requirements for products to ensure complaint position of the company for product distribution.

Responsibilities

1.Track and update key regulatory project deliverables through communications with Regional Managers and members of the Regulatory Department.

2.Monitor regulatory requirements for identified countries and products t assess impacts and assure compliance as appropriate.

3.Support Regional Managers to maintain compliance status by compiling annual reports, reviewing adverse event reports, reviewing product changes and labeling changes, reviewing advertising and promotional materials and taking appropriate actions to assure ongoing compliance for product distribution by country and product.

4.Compile, review, edit regulatory documentation for submission to maintain compliance status for identified countries and products.

5.Participate as an active team member of project teams as required.

6.Prepare and distribute interpretive analysis of key regulatory guidance documents, regulations or directives that impact company products.

7.Maintain open dialog with internal regulatory staff and external consultants to assure ongoing compliance awareness and submissions.

 



Requirements


Computer literate, Word, Excel, PowerPoint, Adobe Acrobat.

Ability to handle multiple projects

Familiarity with submission of regulatory documentation.

Good interpersonal skills.

Excellent organizational, written and verbal communication skills.

Bachelor’s degree preferred.

Two to four years experience in regulatory environment.