Regulatory Affairs Specialist, Robotics (Pittsburgh, PA)

Regulator Affairs Specialist (Pittsburgh, PA)

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

What will you be doing?

• Prepare global regulatory submissions, including EU MDR technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices
• Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology
• Provide support for internal and regulatory agency audits
• Assess engineering change requests (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance
• Review product labeling to ensure compliance with US and international requirements
• Other activities as assigned

What will you need to be successful?

• Education: Bachelor's degree in engineering, Biomedical Engineering or life sciences preferred. RAPS certification a plus.
• Previous applicable internship, co-op, part-time or apprenticeship experience is a plus.

• Strong communication skills including technical writing, listening and speaking with the ability to influence others. Must be able to communicate effectively with cross-functional and international teams, and drive project completion
• High learning agility with the ability to assess issues and develop solutions utilizing an analytical approach to problem solving
• Independent thinking and the ability to work both individually and within a team is required
• Self-motivated and solution oriented; embraces challenges with innovative approaches
• TRavel: 10% foreign and domestic

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: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
• 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
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew is committed to the full inclusion of all qualified individuals. As part of this commitment, Smith+Nephew will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed, please alert the recruiter if you are selected to move forward.

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.