Regulatory Affairs Project Manager

Smith+Nephew•Pittsburgh, PA

3d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

RAPS Certification or RA Master’s degree a plus
PMP Certification a plus

Responsibilities

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.