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

The Regulatory Affairs Specialist is responsible for supporting the development and implementation of the overall objectives and regulatory strategies that impact the introduction of new products, and the market status of existing products. The Regulatory Affairs Specialist I will assist Regulatory Affairs management by supporting the activities and processes required to assure that products manufactured and/or distributed by Smith & Nephew Inc. are in full compliance with U.S. and all applicable international regulatory requirements.

**This position does not offer visa sponsorship**

What will you be doing?

• Prepares international dossiers for EMEA, LATAM, APAC, and other key market affiliates, to obtain and maintain global regulatory approvals of products.

• Interacts with global regulatory agencies to obtain CFG, LoA, etc. as required for product registration. Provides regulatory support for global regulatory teams on international regulatory requirements.

• Supports regulatory strategies for new and modified products.

• Provide customer service necessary regulatory / registration information for compliance and customer requests.

• Support manufacturing changes for compliance with applicable regulations.

• Update company databases with required information and statuses for licenses, registrations, renewals, products, and other required data, i.e. GUDID, DI, EUDAMED, RIMSYS, and management of SAP for legal blocks and registrations.

• Update and maintain knowledge of current developments and changes to applicable laws, regulations, and industry standards.

• Support development of company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.

• Provide support for internal and Regulatory Agency audits.

• Build Quality into all aspects of job performance by maintaining compliance to all quality requirements.

• Participates in training and development activities as required and other duties 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: 0-2 years of Regulatory experience within the Medical Device industry preferred

• Good interpersonal/communication skills are essential.

• Travel Requirements: 10-20% (audit support)

**To be considered for this role, please submit your application by 8/07/2024”.

The anticipated compensation range for this position is $63,750.00 - $85,000.00 USD annually and the compensation offered will depend on the candidate’s qualifications. You may also be entitled to receive bonus and benefits, which may include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.

Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by the by local and state policies.

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 (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

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#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.