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Andover

    Regulatory Affairs Specialist - Andover, United States - Smith+Nephew

    Smith+Nephew
    Smith+Nephew Andover, United States

    1 week ago

    Default job background
    Full time
    Description

    Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

    This role will be focused on the continuously growing Sports Medicine franchise at Smith + Nephew that serves our patients and customers to live Life Unlimited. This position is ideal for an eager regulatory affairs professional. In this role, you will support regulatory activities for currently marketed devices and new product development.

    What will you be doing?

  • Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.
  • Provides support for internal and external audits.
  • Provides regulatory guidance and support as a core team member on development and manufacturing teams, as well as compliance projects, throughout the product development life cycle, and identifies/coordinates cross functional deliverables and support for submissions.
  • Develops and implements regulatory strategies for new and modified products and regulatory processes and prepares submissions to obtain and maintain global regulatory approvals of products, providing oversight of device labeling and advertising and promotional materials to ensure continued compliance to global regulations.
  • Ensure regulatory compliance throughout the product lifecycle by assessing product changes for impact to global market registrations.
  • Reviews and approves product and manufacturing changes for compliance with applicable regulations.
  • Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
  • Other activities as assigned.

    • What will you need to be successful?

  • Education: bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline
  • Experience: 1-2 years in Regulatory Affairs or equivalent experience related medical industry development.
  • Travel Requirements: <10%

    • 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 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
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