Apothecary Products

  • Regulatory Affairs Associate

    Job Locations US-MN-Burnsville
    Posted Date 7 days ago(9/9/2019 9:29 AM)
    Category
    Quality/Regulatory
    FLSA Status
    Exempt
    Type
    Regular Full-Time
  • The Career - What it is:

    Regulatory Team Picture2

    The APL Quality + Regulatory team

    Clockwise from top left corner: Russ Davies (Director, Quality + Regulatory), Alex Hutton (Quality Assurance Supervisor), Ty Luepke (Quality Inspector), Marshall Borgen (Quality Inspector), Pax Her (Regulatory Affairs Manager), Theresa Brink (Quality Systems Specialist).

     

     

    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.

     

    Note: Relocation costs are not included in this opportunity. 

     

    In this role the incumbent will:

    • Research regulatory requirements and aid with cost-effective implementation.
    • Assist in ensuring all domestic and international regulatory affairs activities are compliant with ISO 13485, European Directives and Regulations, US FDA regulations, and GMP requirements, among others.
    • Assist in the creation and maintenance of clinical evaluations, technical files, risk management files, biological safety assessments, labeling, and other technical information.
    • Aid in the review of artwork to ensure that specific product or performance claims meet regulatory requirements
    • Work alongside cross-functional teams to deliver quality and compliant products in a variety of categories such as OTC drug, consumer products, medical devices, dietary supplements, and food.

    Click here for the full job description

    Qualifications + Experience:

    We seek applicants with these critical skills and experience:

    • Bachelor’s Degree in Life Sciences.
    • 0-1 year experience in a regulatory-related position; consideration given to applicable internship in related field.
    • Working knowledge of domestic and international regulatory compliance requirements (e.g. product registration, technical files) and procedures.
    • Ability to analytically assimilate regulatory information and effectively translate these into practical approaches.
    • Excellent interpersonal and communication skills including verbal, written and presentation skills.

    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: 9 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!

    Interested?

    Learn more and apply at www.apothecaryproducts.com

     

    Posted: 8-15-2019

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

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