Senior Regulatory Affairs Specialist (Memphis, TN)

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

Are you passionate about navigating regulatory landscapes? Do you thrive in fast-paced environments? We're looking for a Regulatory Affairs Specialist to join our team and drive regulatory strategies for our cutting-edge products. If you're ready to make an impact, apply now!

What will you be doing?

• Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices

• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets.

• Manage/lead regulatory-driven project, as directed by management.

• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products

• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology

• Plan, lead and support for internal and Regulatory agency audits

• Lead and direct engagement with regulatory authorities as required

• Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance

• Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.

• Review product labeling to ensure compliance with regulatory requirements

• 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 required.

• Licenses/Certificates

  • RAPS Certification or RA Master's degree a plus

• Experience:

  • Minimum of 5 years regulatory experience or equivalent within the medical device industry required.

• Demonstrated experience with successful Submissions in key markets such as US as EU.

• Demonstrated knowledge of regulatory requirements, standards and guidance for medical devices

• Experience working with large cross functional teams and diverse groups.

• Processes and Product Lifecycle Management Systems experience is required

• Good interpersonal skills are essential

• Strong communication skills including technical writing, listening and speaking

• High learning agility with the ability to assess issues and develop solutions utilizing an analytical approach to problem solving

• Independent thinking and the ability to work both individually and within a team is required

• Self-motivated and solution oriented; embraces challenges with innovative approaches

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

• Able to read, understand, and apply regulations

• Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc)

• Ability to respond to inquiries from regulatory agencies - written and in person.

• Ability to write detailed technical regulatory submissions, reports and business correspondence

• Travel Requirements: 10%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion and Belonging-Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more aboutEmployee Inclusion Groupson our website (https://www.smith-nephew.com/).

Other reasons why you will love it here!

• Your Future: 401k 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

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.