Global Regulatory Manager (Contract)

Frida•Remote, OR

16h•Remote

About The Position

Frida is seeking a Global Regulatory Manager (Contractor) to join our Quality and Regulatory team based in Remote. Reporting to the Senior Director, Quality & Regulatory, this role will take the lead in ensuring that Frida'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, Saudi FDA, etc.). This person will manage regulatory responsibilities associated with the sourcing, 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. The Global Regulatory Manager (Contractor) will thrive in a dynamic, fast-paced, and entrepreneurial environment.

Requirements

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
Ability to work in a fast-paced environment in which requirements & priorities constantly change
Excellent written and verbal communication
Consumer obsessed and possess strong consumer understanding
Excellent communicator with strong written, verbal, and presentation skills
Ability to manage multiple projects at once and strong organizational skills
Proactive; can operate autonomously, but also collaboratively as part of a team

Responsibilities

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)

Benefits

Comprehensive medical, vision, and dental plan options
Employer paid life insurance
Supplemental insurance options including Accident Insurance, Short-Term Disability and Long-Term Disability, Cancer Coverage, and more
FSA & HSA
401k matching up to 4% with immediate vesting
Generous paid time off program including elective PTO days, federal holidays, sick/wellness days, floating holidays, and a birthday day off!
Pregnancy and parental leave
Weekly wellness programming in-office
Dog friendly office
Learning & development opportunities for professional and personal growth
Company-wide events & outings
Annual Day of Service to support our local Miami community
Variety of volunteer opportunities throughout the year
Exclusive employee product discounts