Apothecary Products

  • Regulatory Affairs Specialist

    Job Locations US-MN-Burnsville
    Posted Date 4 weeks ago(2/3/2020 5:06 PM)
    FLSA Status
    Regular Full-Time
  • The Career - What it is:

    Apothecary Products (APL) is currently seeking a Regulatory Affairs Associate to grow our R&QA team. In this role, you will be accountable for the timely execution of regulatory plans and associated tasks for products the company offers. You will research regulatory requirements and assist in ensuring regulatory systems are maintained to support existing and new products. Your work will be within a broad spectrum of consumer products including OTC drug, medical devices, dietary supplements, and food. 



    In this role the incumbent will:

    • Ensure regulatory processes, procedures and records meet regulatory requirements by utilizing multiple sources
    • Liaise with governmental regulatory and quality agencies in resolving regulatory and/or product related issues
    • Assist with domestic and international regulatory affairs activities including ISO 13485, European Directives and Regulations, US FDA regulations, and GMP requirements among others
    • Ensure marketing materials, such as licenses, approvals and registrations, are obtained and maintained to meet requirements
    • Determine testing requirements for children’s products to ensure CPSIA compliance and creates certificates

    Click here for full job description


    Qualifications + Experience:

    We seek applicants with these critical skills and experience:

    • Bachelor’s Degree in Life Sciences or related field preferred
    • 2+ years of regulatory work experience in a regulated industry is required
    • Working knowledge of 21 CFR parts 820 (med device), 111 (dietary supplements), 210 and 211 (drug products)
    • Working knowledge of ISO 13485:2016, EU Cosmetic Regulations, Medical Device Directives and Regulations
    • Internal Quality System Auditing experience


    The Company - Why APL:

    APL is a leading innovator, manufacturer, marketer and supplier of simple self-care solutions, pharmacy supplies and wellness aids. We are based in Burnsville, MN with several manufacturing and vendor partners in the US and internationally. APL has pioneered many strong consumer product categories, including medication management. We have many trusted brands in the marketplace and do business with well-known mass retailers, grocery and chain drug stores. We've also got a great culture embedded in our WE CARE values that helps ensure we have a lot of fun each day and are a high-performing work team.



    The Rewards - What We Offer:

    The rewards we provide recognize and retain collaborative, results-oriented, strong contributors. Our comprehensive programs support team members and their families in their efforts to live healthy lives. We strive to create opportunities for career growth and financial success – all while being an agile employer committed to open communication. Rewards include:

    • Annual incentive program, discounts on products and employee assistance programs
    • Team member + family insurance programs including employer contributions: Medical, Dental, Life and AD&D, Short-term and Long-term Disability
    • Vision, Pet, Legal, and Identity Theft insurance programs
    • Financial wellness benefits including: Health Savings Account, Dependent Care Savings Account, and 401k 
    • Work/life blend: 10 company-paid holidays, Paid Time Off starting at 3 weeks, Paid Volunteer Time, and summer hours
    • Onsite wellness activities: onsite community garden, Yoga, Volleyball, and walking clubs
    • Community giveback opportunities supporting local and national charities
    • Relaxed work environment: casual dress every day of the week, food trucks and many team activities!


    Learn more and apply at www.apothecaryproducts.com


    Posted: 2/3/2020

    EOE/M/F/Vet/Disability. No agency calls at this time. 


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