• Regulatory Affairs Specialist

    Job Locations US-WI-Madison
    Req No.
    2018-3067
    Category
    Quality Assurance & Regulatory Affairs
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Regulatory Affairs Specialist writes, files, and obtains approvals for domestic and international regulatory submissions per registration strategies. The Regulatory Affairs Specialist helps define the regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives, and executes to that plan. Assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.

    Essential Duties and Responsibilities

    • Assists in preparation and management of regulatory submissions and/or other premarket registration activities to acquire appropriate commercial distribution approvals and/or clearances.
    • Contributes to and documents appropriate regulatory strategies for proposed new products and initiates necessary activities by working with project teams and regulatory management as needed.
    • Controls and maintains regulatory records.
    • Represents Regulatory Affairs on various project teams by attending team meetings and providing the required regulatory plans, procedures, and pertinent decisions.
    • Confers with Regulatory Affairs SMEs regarding regulatory requirements of new product designs and/or changes to existing designs.
    • Reviews and approves new documents and product changes for regulatory compliance, including identification of potential registration requirements for such changes.
    • Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry and contributes to department continuing education activities for regulatory knowledge sharing.
    • Reviews and approves product labeling and marketing material. Initiates new package inserts and other required product labeling in alignment with registration strategies.
    • Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations and policies applying to medical devices (including PMAs, 510(k)s, and post-market submissions and reporting), labeling and promotional materials, global registration, and technical writing.
    • Ability to use computers daily in an interactive manner for extended periods of time.
    • Ability to sit for an extended period of time.
    • Ability to frequently and accurately communicate with employees in person, via the telephone or by email.

    Qualifications

    Mandatory Skills

    • Strong technical writing skills.
    • Effective communicator; able to convey messages in a logical and concise manner.
    • Consistently reinforces regulatory expectations and requirements.
    • Exceptional attention to detail with strong organizational skills.
    • Independent self-starter; manages time effectively and completes tasks on-time with minimal supervision.
    • Flexible and able to self-manage multiple priorities.
    • Adapts readily to changes in workload, staffing, and scheduling.
    • Conducts self in a professional manner with coworkers, management, customers, and others.
    • Models the corporate values.

    Education and Experience

    • Bachelor’s degree in science or health-related discipline with at least one internship in regulated pharmaceutical or medical device environment OR High School Diploma or General Education Degree (GED) and four years of experience working in a regulated pharmaceutical or medical device environment in lieu of degree.
    • 2+ years relevant experience in regulated pharmaceutical or medical device environment.
    • Working knowledge of creation and modification of product labeling.
    • Familiarity with adverse event reporting, post-market surveillance, and vigilance requirements.

    #LI-AS2

    We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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