Regulatory Affairs Specialist I (Memphis - Goodlett Farms)

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

Role Overview:

The role will be part of a collaborative and energetic team working on regulatory submissions and compliance maintenance for Smith Nephew. This role provides an exciting opportunity for someone to innovate and optimize processes as well as contribute to high-impact projects within the medical device industry.

What will you be doing?

• Author and compile product submissions and technical files

• Support cross-functional projects through the provision of regulatory submission/compliance strategy document, regulatory inputs, and documentation reviews (CER, IOVV, Risk Management Documentation, etc.)

• Author labeling literature (IFU, Patient Implant Leaflets), review package labeling, and review advertising/promotional material.

• Assess changes to existing devices (ECRs, Supplier Changes, Manufacturing Transfers) for regulatory impact and submit or support regional change submissions.

• Support technical file and quality audits.

Education:

Bachelor's degree in engineering or closely related discipline. Will also consider applicants with BA or BS in Business Administration, Life Science, nursing, medical technology or related discipline with 3 or more years of prior experience in the medical industry.

Experience:

• Minimum 0 - 2 years of Regulatory experience within the Medical Device or Pharma industry.

Licenses/Certifications:

• ISO Auditor certification and or RAC preferred.

Competences:

• 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.

• Experience working with large and diverse groups.

• Knowledge of current EU regulations is preferred

• Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results.

• Ability to communicate effectively and work within international multidisciplinary team.

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence. Ability to effectively present information and respond to questions from groups of managers clients, customers and the general public.

Mathematical Skills:

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands:

Office work and some out-of-hours work will be required.

Travel Requirements:

5-10%

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 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

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more.

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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.