Regulatory Affairs Project Manager

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

Are you passionate about navigating regulatory landscapes as well as project management? Do you thrive in fast-paced environments? We're looking for a Regulatory Affairs Project Manager to join collaborative and energetic team working on regulatory submissions and compliance maintenance for Smith+Nephew. If you're ready to make an impact, apply now!

What will you be doing?

• Collaborate with regulatory team members, cross-functional teams and regulatory bodies to plan and schedule regulatory submissions.

• Create and manage project plans, when needed, for regulatory projects using input from stakeholders.

• Manage/lead regulatory-driven projects and ensure timely receipt of submission supporting documents from cross-functional teams for a timely submission.

• May support preparation, review and/or approval of global regulatory submissions, including US and EU, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices

• Work as the RA lead and SME on project teams independently to develop regulatory strategies, testing requirements and other documentation to ensure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.

• Regularly communicate with Business stakeholders on regulatory approval timeframes

• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products 

• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology

• Plan, lead and support for internal and Regulatory agency audits, as needed

• Lead and direct engagement with regulatory authorities as required

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams and act as SME for colleagues with less experience.

• Other activities as assigned.

What will you need to be successful?

• Education: Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline

  • RAPS Certification or RA Master’s degree a plus

  • PMP Certification a plus

• Experience: 8+ years experience in Regulatory Affairs

• 5+ years experience with successful submissions or 2+ years Project Management experience.

• Demonstrated experience with high risk classification devices. (Class II & Class III)

• Knowledge and practical application of medical device regulations (ISO, GMP, FDA, CE, EU MDR) and design controls.

• Experience with internal/External Audits, Quality Systems expertise and clinical study experience beneficial

• Experience working with large cross functional teams and diverse groups.

• Processes and Product Lifecycle Management Systems experience is required

• Travel Requirements: <15%

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients 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/).

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, 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!  

The anticipated base compensation range for this position is $119,500 - $179,000USD 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. 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. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

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.