Apothecary Products

  • Regulatory Affairs Specialist

    Job Locations US-MN-Burnsville
    Posted Date 4 weeks ago(7/27/2018 1:14 PM)
    Category
    Quality/Regulatory
    FLSA Status
    Exempt
    Type
    Regular Full-Time
  • Overview

    Apothecary Products (APL) is currently seeking a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will provide strategic and tactical direction for all regulatory aspects for products and services that the company offers. This role also ensures that all applicable regulatory requirements are satisfactorily met in the countries and regions served. Areas of focus include medical devices (predominantly Class 1), cosmetics, dietary supplements, over-the-counter (OTC) drugs, children’s products, and consumer goods.

     

    We seek out only the best - the best skills, the best attitudes and expect the best results from our team members. In return, we will not only offer a highly competitive compensation and benefits package but the training, development and support to make our team members a success in whatever they do for us. Apothecary Products peers and management will be the foundation for energetic, eager individuals to thrive.

     

    Responsibilities

    In this role the incumbent will:

    • Ensure product specifications and documentation meet applicable regulatory requirements and are properly maintained across all functions.
    • Provide practical guidance and technical expertise to ensure all necessary domestic and international regulatory affairs activities are in governmental compliance, including but not limited to: US FDA regulations; ISO 13485; European Medical Devices Directive; GMP requirements; and Company Policies.
    • Respond to customer requests for regulatory and compliance related information.
    • Coordinate the creation and maintenance of risk management files for products and processes to support technical files and submissions.

    Click here for more details and full job description.

    Qualifications

    We seek applicants with these critical skills and experience:

    • Bachelor’s degree in regulatory-related field
    • 3+ years Regulatory work experience in a regulated industry
    • Work experience in regulations and standards applicable to medical devices (predominantly Class 1), cosmetics, topicals, dietary supplements, over-the-counter (OTC), consumer goods, and children’s products
    • Ability to negotiate critical points regarding devices to the favor of corporate objectives (e.g. reduce costs associated with regulation and/or marketing objectives)
    • Effective leadership and team facilitation skills to motivate cross-functional staff to deliver information related to submission preparation and/or direct technical and sales marketing product literature review

    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 – in fact, our original owner invented the pill box! 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
    • Team member and family insurance programs including employer contributions, including, medical, dental, life, AD&D, short-term and long-term disability
    • Vision, pet, legal, accident and critical illness insurance programs
    • Financial wellness benefits including savings account and for health and dependent care expenses and 401k
    • Discount and employee assistance programs
    • Work/life blend: 9 paid holidays and time off starting at 3 weeks plus summer hours and paid volunteer time
    • Onsite wellness activities including on-site community garden, yoga, volleyball, and walking clubs
    • Community giveback opportunities supporting local and national charities
    • Casual dress every day of the week, food trucks and many team activities!

    Interested - How to Apply:

    External applicants should apply at www.apothecaryproducts.com 

     

     

    EOE/M/F/Vet/Disability 

    No agency calls at this time. 

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