Senior Regulatory Affairs Specialist

Mansfield, United StatesHybrid

Requirements

Bachelor’s degree or equivalent experience, preferably in a scientific or technical discipline 5 or more years of Regulatory Affairs or related
experience within the medical device industry Proven
experience managing FDA 510(k) submissions and EU MDR filings Strong understanding of global regulatory

requirements and medical device development processes Excellent written and verbal communication skills, including technical writing RAPS certification is an advantage The anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate’s qualifications, job-related knowledge/skills, geographical location.
You will be entitled to receive bonus and benefits, which 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 local and state policies. You Unlimited.
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, 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

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/).

At Smith+Nephew we design and manufacture technology that takes the limits off living.
Are you a regulatory affairs professional who enjoys working at the intersection of innovation, compliance, and patient impact? Join our growing Sports Medicine franchise and play a key role in supporting life changing medical technologies used by patients around the world.
This is an opportunity to work collaboratively with global teams while shaping regulatory strategy across the full product lifecycle.
Developing and executing global regulatory strategies for new and modified medical devices Preparing and managing regulatory submissions to obtain and maintain global market approvals Providing regulatory guidance to cross functional teams across product development, manufacturing, and compliance activities Assessing product and manufacturing changes to ensure continued regulatory compliance throughout the product lifecycle Acting as a company representative with global regulatory agencies, building and
We believe in creating the greatest good for society.
Our strongest investments are in our people and the patients we serve.
We're more than just a company - we're a community! Follow us on L inkedIn to see how we support and empower our employees and patients every day.
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benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.