startwire

Regulatory Director

Starface World Inc
 Remote

We are Starface

Starface World is reinventing the way we care for acne-prone skin as the first complexion brand to combine efficacy and optimism. We take skincare concerns that were once thought of as flaws and translate them into an opportunity for expression.

Starface World is a positively uplifting place where everyone is safe & accepted exactly as they are. We support causes and do our own work in the world to help build a better, more supportive universe. The same thinking applies to the way we care for skin: we don’t identify flaws or imperfections, we just nurture what’s there—it’s perfect because it’s all just skin.

Our team is a small (but growing) group of committed individuals who are passionate, empathetic, creative, and eager to learn. We are committed to a sustained focus on diversity, equity, anti-racism, and inclusion.

Your Impact at Starface

As Starface expands into new product markets and grows its product portfolio, the Regulatory Director will be responsible to streamline regulatory affairs and ensure full product and organizational compliance for the Starface organization as we continue to expand into new markets. This role reports directly to the President of Starface.

Working closely with the VP of Product Development you will evaluate formula submissions, provide feedback and re-directs, select submissions to be presented back to key stakeholders, and define new products concepts and benchmarks. This role will be instrumental in validating and addressing regulatory compliance for ongoing SKUs and new product innovation for the company.

We will count on you to do:

  • Manage Regulatory Compliance
    • Act as the PRRC (person responsible for regulatory compliance) for Starface and ensure individual certifications are in place and remain current to meet the expectations of this position
    • Work with regulatory legal representation, external consultants, suppliers, retailers, and distributors to compile, supply, and upload documentation as needed for new product registrations and regulatory filings (ILs, SDS, COA, certifications, test results, etc); provide documents to internal team for system setup
    • Maintain partnerships with external contacts (RP, consultants, suppliers, distributors, contract manufacturers, and 3rd party regulatory agencies) to ensure quality, safety, and regulatory compliance of all products
    • Work with RP and external consultants to create, collate, and/or manage PIF documentation for submission to 3rd party regulatory agencies and retail partners
    • Conduct US filings (VCRP, SB 484, etc.) and global product registrations/filings
    • Keep organization abreast of regulatory changes (ie, new registration requirements, Prop 65, Clean Beauty guidelines, MoCRA, etc) and perform regulatory duties to ensure product and company compliance
  • Support New Product Development Processes
    • Ensure all new product formulas are globally compliant as we expand into new markets
    • Compile ingredient documentation requirements to ensure compliance with Starface formulation guidelines, supporting product claims and registrations
    • Conduct reviews and act as the regulatory gatekeeper for all artwork review, labeling, and claims (ie, pack labels, websites, inserts, ads, brochures, etc.); provide clear labeling guidance and train affected stakeholders on requirements
    • Coordinate new product testing (stability, HRIPT, SDS)
  • Other Responsibilities
    • Ensure all new and existing products have compliant packaging, labeling, and formulas
    • Liaise with all cross-functional stakeholders and represent regulatory in meetings as needed to provide risk-management insights, reformulation updates, and testing/ regulatory advice, as necessary
    • Interface regularly with internal teams to collaborate on initiatives such as the QMS implementation and maintenance, label compliance reviews, artwork and package innovation projects, etc.
    • Implement Regulatory Compliance systems, processes, and procedures as necessary to execute the functions of this role
    • Document information and findings from any audits or regulatory compliance reviews and create roadmaps to address areas of improvement
    • Prepare reports.metrics to communicate and track regulatory compliance status

Who we are looking for

  • Minimum Bachelor’s Degree or Advanced Degree in medicine, pharmacy, engineering, or science
  • 5+ years of experience in Medical Devices regulatory affairs and expertise in global in-market compliance, including experience in cosmetics and/or personal care
  • Qualifications to act as PRRC (person responsible for regulatory compliance) including appropriate degree/certification and 1+ year regulatory/QA experience in medical devices or 4+ years regulatory/QA experience in medi devices
  • Experience working on regulatory compliance for OTC / SPF products
  • Experience with US and global market supplier registrations and product registrations/labeling requirements for medical devices, skincare, and personal care
  • Strong knowledge and experience managing compliance for FDA regulations, cGMP’s, 21 CFR, ISO 13485, CFR 820, MDSAP, and MDR
  • Understanding of new MoCRA requirements and ability to ensure compliance
  • Familiarity with technical transfers and onboarding new contract manufacturing partners and/or suppliers
  • Excellent organization skills, ability to prioritize multiple tasks, exceptional attention to detail; highly autonomous
  • Proven track record of taking ownership and driving results
  • Strong collaboration skills; ability to partner cross-functionally on key initiatives
  • Experience with Word, Excel, PowerPoint, Google Docs, and DropBox; Greenlight Guru expertise is a plus
  • Ability to work in fast-paced, ever-changing, start-up collaborative environment
  • Willingness to work on administrative tasks and “no task is too small” attitude

Salary and Benefits:

  • Remote team
  • Compensation for this role is $135 - $170k depending on experience
  • Current benefits include:
    • Access to high-quality health care options
    • Access to a 401k with 5% employer match
    • 4 weeks of vacation plus 15 paid holidays
    • Maternity, Paternity, and Pet-ternity options
    • Home office stipend

If you need any assistance with your application please contact careers@starfaceworld.com.

Starface World Inc. is an Equal Opportunity Employer. Starface does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All information provided by the applicant is collected, stored and processed in accordance with the terms of our Privacy Policy.

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