Global Regulatory Manager (Contract) bei Frida

Description

Who We Are

Parenting isn't picture-perfect. It's messy, hilarious, exhausting, and life-changing — sometimes all before noon. That's where we come in.

Founded in 2014 by our CEO Chelsea Hirschhorn, Frida was built to make the raw reality of parenting a little easier to navigate (and a lot less overwhelming). It all started with one legendary snot-sucker — the NoseFrida — and has grown into a 200+ product lineup that supports families through every stage: from fertility and postpartum recovery to baby care and beyond.

We don't shy away from the stuff no one else wants to talk about — nipple pain, diaper blowouts, or the emotional rollercoaster that comes with keeping a tiny human alive. We call it like it is, solve the problems that actually matter, and build products that help parents feel seen, supported, and totally capable.

You can now find Frida products in 50+ countries and thousands of stores across the U.S., from the biggest national retailers to your neighborhood grocery aisle.

Under Hirschhorn's leadership, Frida has become a category leader by challenging taboos, championing honesty, and supporting families at every stage of parenthood and beyond, earning acclaim on TIME's 100 Most Influential Companies, TIME Best Inventions, Fast Company Most Innovative Companies and Fast Company Brands That Matter. But the real win? Knowing we're helping parents everywhere feel a little more human and a little less alone.

How You Will Make an Impact

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.

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
• 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

Who You Will Work With

Frida is an organization that values collaboration and community. As the Global Regulatory Manager (Contractor), you will work closely with the regulatory and quality teams, as well as cross-functional business partners including Product Development, Marketing, and Legal.

Why You Will Love Working at Frida

We offer a comprehensive and thoughtfully designed benefits package to support our employees:

• Robust health benefits including:
• 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

EEO

Frida provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected Veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Privacy Policy

By applying for this position, you acknowledge and understand that your information will be used as described in Frida's Job Applicant Privacy Policy: https://frida.com/pages/fridababy-job-applicant-privacy-policy

Agency and Third-Party Submissions

Please note this is a direct search led by Frida. Applications from agencies and other third parties will not be accepted, nor will fees be paid for unsolicited resumes.

Fraud Disclaimer

Fridababy LLC will never request personal information (i.e. Social Security number, bank account, or payment of any kind) during the application or recruitment process. Fridababy LLC will only contact you through verified methods, not unofficial platforms such as WhatsApp, Telegram, or personal email accounts. All legitimate communication will come from an official @frida.com or @fridababy.com email address or through our verified recruiting partners.

If you receive any suspicious outreach claiming to represent Fridababy LLC, please report it to [email protected] or [email protected]. Your safety and privacy is our priority.