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    Regulatory Affairs Manager - Memphis, United States - Smith & Nephew

    Smith & Nephew
    Smith & Nephew Memphis, United States

    3 weeks ago

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    Description
    Regulatory Affairs Manager page is loaded

    Regulatory Affairs Manager

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    locations

    Memphis, TN

    US - Field

    time type

    Full time

    posted on

    Posted 3 Days Ago

    job requisition id

    R75583

    Life Unlimited.

    At Smith+Nephew we design and manufacture technology that takes the limits off living.
    Attention Regulatory Mavericks Regulatory Affairs Manager Wanted
    Are you driven by helping patients live their life unlimited? We're seeking a Regulatory Affairs Manager to lead the charge in ensuring compliance and driving innovation in our dynamic industry
    What will you be doing?
    Responsible for the creation and execution of global regulatory strategies for new product development activities and all medical devices through their product lifecycle


    Directly, or through subordinate staff, develops regulatory submissions and dossiers; conducts submission negotiations with regulatory agencies, as needed, including pre-submission identification of requirements and strategy to ensure timely approval.


    Responsible for resourcing NPD programs and portfolio maintenance activities, translating regional regulatory needs into project inputs and ensuring those inputs become deliverables that can be provided to regional team members to facilitate the preparation of new submissions, product renewals, tender requests, etc.

    Builds effective partnerships with RA teams across franchises and regions and with appropriate functional teams (e.g., program management office (PMO), marketing, research and development (R&D), quality, operations)


    Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.

    Assists in the development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary.


    Provides support for internal and external regulatory agency audits, corrective and preventive action (CAPA) activities, health hazard evaluations (HHE) and field actions.

    What will you need to be successful?

    Education:
    bachelor's degree preferably in an engineering, clinical, medical, or scientific/technical discipline; Biomedical engineering degree preferred but not required


    Experience:
    Minimum 5 years Regulatory experience required and medical device experience preferred.

    1-2 years supervisory experience preferred.

    Orthopedic device experience preferred.

    Good

    interpersonal/communication

    skills are essential.

    Experience of providing Regulatory Advice to the business is essential.

    Ability to handle multiple demands in a fast-paced environment.

    Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, proven ability to influence cross-functional teams, strong planning and analytical skills


    Leadership if any:
    People Manager (team of 3-5)


    Travel Requirements:
    You. Unlimited
    We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
    Inclusion, Diversity and Equity-

    We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups

    on our website (

    ).
    Other reasons why you will love it here
    Your Future: 4 01k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement

    Work/Life Balance:
    PTO, Paid Holidays, Flex Holidays, Paid Community Service Day


    Your Wellbeing:
    Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

    Flexibility :
    Hybrid Work Model (For most professional roles)


    Training:
    Hands-On, Team-Customized, Mentorship


    Extra Perks:
    Discounts on fitness clubs, travel and more
    #LI-LS2
    #LI- REMOTE

    Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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    talent community

    .
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    more than just a company -

    we're

    a community Follow us on

    LinkedIn

    to see how we support and empower our employees and patients every day.
    Check

    our

    Glassdoor page

    for a glimpse behind the scenes and a sneak peek into

    You

    .

    Unlimited

    .

    , life, culture, and benefits at S+N.
    Explore our

    new website

    and learn more about our mission, our team, and the opportunities we offer.
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