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

We believe that through innovation, development and supporting our customers and patients we can help others achieve a Life Unlimited. Long before any of this is possible, we must go through many steps that will validate and verify our products.  Regulatory Affairs plays a vital part in the process! You can play an important role in preparing and supporting both US and international regulatory submissions and strategies for our growing portfolio.

The role of the Sr. Regulatory Affairs Specialist involves developing global regulatory strategies and leading the associated registrations or submissions to achieve market clearance or approval. You will provide regulatory guidance to project teams on product development and design control activities, ensuring compliance throughout the product lifecycle by evaluating changes for their impact on registrations and licenses.

Join us and play a pivotal role in bringing cutting-edge medical devices to markets worldwide!

What will you be doing?

You'll ensure our medical devices meet global regulatory standards and lead the preparation and review of regulatory submissions, develop strategic plans, and collaborate with international teams with launches and market expansions. Your expertise will guide our compliance efforts, influence regulatory strategies, and drive successful engagements.

Preparing and reviewing global regulatory submissions for devices containing both hardware and software, including US 510(k) and EU technical documentation, and support regional colleagues with international submissions for new and modified devices.

Leading regulatory affairs on project teams to develop strategies, testing requirements, and documentation, ensuring timely regulatory approvals for product launches.

Developing and implementing global strategies to support product releases and market expansion for products.

Planning, leading, and supporting internal and regulatory agency audits.

Leading and directing interactions with regulatory authorities as needed.

Initiating and handling regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impacts on product registrations, updating as required to maintain compliance.

Developing and maintaining company Standard Operating Procedures (SOPs) to ensure compliance with global regulatory requirements.

Reviewing product labeling to ensure it meets regulatory requirements.

This role ensures that products provided to patients are safe and effective, exercising regulations with a foundation of ethics and care.

What will you need to be successful?

Bachelor’s degree, preferably in a scientific, engineering, or technical field, plus 4 -7 years’ experience in Regulatory Affairs.

Experienced in US & EU MDR regulatory requirements is required.

Experience with devices that include both hardware and software components is preferred.

Completion of a 510(k) submission for a device that includes software, artificial intelligence (AI), machine learning, or other similar technology is highly preferred. 

The ideal candidate is driven and a go-getter, capable of taking complex technical information, synthesizing it, and putting it into practice effectively. You'll be guided by acting ethically, as this notion sits at the heart of our team.

You'll be a creative and independent problem solver with strong critical thinking skills, adept at finding solutions where not everything is black and white.

The anticipated compensation range for this position is $126,500.00 - $135,000.00 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew.  Compensation decisions are dependent upon the facts and circumstances of each position and candidate. 
 

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.

Stay connected and receive alerts for jobs like this by joining our talent community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our new website and learn more about our mission, our team, and the opportunities we offer.