We are seeking a Global Regulatory Affairs Specialist to join our Quality and Regulatory team that takes the lead in ensuring that the company's operations adhere to the laws regulating the CPG and medical device industries globally. The right person will have knowledge of FDA, GxP and CPSC regulations as well as be able to navigate the regulations of their global counterparts (Canada, Mexico, EU, UK, Switzerland, Saudi FDA, etc.). This person will manage regulatory responsibilities associated with product development, support and manufacturing of the company’s medical device, OTC and general use products, including but not limited to: product registrations, license renewals, resolving compliance issues, staying abreast of regulatory changes, and liaising with outside parties to ensure compliance in global markets. Responsibilities to include:

• Manage the development and implementation of regulatory strategies and plans to support the timely introduction of new products and the preparation/review of international regulatory submission(s) (EU MDR Tech File, Health Canada submission, Saudi FDA, etc)
• Represent international regulatory interests on cross-functional project team for new and existing products
• Review and approve labeling requirements for global market(s); translation material, claims review, IFU, etc.
• Evaluate change proposals for international regulatory impact
• Maintain effective communication within the RA/QA group, as well as, cross-functional business partners, i.e. Product Development, Marketing, Legal, etc.
• Support Regulatory and Quality Departments efforts in maintaining ISO 13485 and MDSAP Certifications (internal audit, NB audits, SOP compliance, etc)
• May provide direct supervision of individual(s)

What You Will Need

• Bachelor's degree in Science, Engineering, Pharmaceutical discipline(s)
• Direct experience with international regulatory affairs (submissions, License renewals, TF, etc.)
• A minimum of 3 years in a medical device, pharmaceutical or similar organization
• Ability to handle competing priorities and deadlines
• Highly organized, meticulous with a great attention to detail
• Able to work independently as well as in teams
• Result-oriented, creative and able to multitask
• Great communication skills both verbally and written
• Experience of working within the requirements of 21 CFR 820, ISO 13485, MDSAP, the Medical Devices Directive (93/42/EEC) and European Medical Device Regulation 2017/745.

Who You Will Work With

As the Global Regulatory Specialist, you will work closely with Brand Management, Project Management, Marketing, and Sourcing teams.