Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
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
**This position does not offer visa sponsorship now or in the future.**
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.)
Assess changes to existing devices (Change Requests, Supplier Changes, Manufacturing Transfers) for regulatory impact and submit or support regional change submissions.
Support regional registration and renewal requests.
Author labeling literature (IFU, Patient Implant Leaflets), review package labeling, and review advertising/promotional material.
Support technical file and quality audits.
What will you need to be successful?
Education: Bachelor’s degree required in Life Sciences, Business Administration, Nursing or Medical Technology or Master’s degree in Regulatory Affairs.
Experience:
0-2 years of Regulatory experience within the Medical Device industry preferred
Knowledge of current US and EU regulations is essential.
Good interpersonal/communication skills are essential.
Ability to handle multiple demands in a fast-paced environment.
Experience working with large and diverse groups.
Ability to communicate effectively and work within international multidisciplinary team.
Travel Requirements: 5-10%
"To be considered for this role, please submit your application by 09/17/2024."
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
#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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