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Frida

Frida Baby, also known as Fridababy or simply Frida, is an award-winning company dedicated to providing tools and tips that help simplify parenthood. In past hi

Global Regulatory Manager – Contract

Location

Oregon

Posted

33 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Global Regulatory Manager – Contract

Frida

• 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)

Job 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

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 - feel free to bring your best buddy with you to work!
  • Learning & development opportunities for professional and personal growth
  • Company-wide events & outings. Team engagement is at the center of our culture. This ranges from small department-specific teambuilding or informal outings to our annual Fam Jam family carnival that celebrates the people in your life who support you in bringing your best self to work each day. We also host an annual Day of Service to support our local Miami community, and provide a variety of volunteer opportunities throughout the year that support our mission to serve parents and children.
  • Exclusive employee product discounts

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