[Hiring] Senior Regulatory Affairs Specialist @Smith and Nephew

Role Description

The Senior Regulatory Affairs Specialist will be responsible for:

• Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation.
• Supporting regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.
• Working as the RA lead on project teams to develop regulatory strategies, testing requirements, and other documentation to ensure regulatory submissions meet product launch timelines.
• Managing and leading regulatory-driven projects as directed by management.
• Developing and executing global regulatory strategies to support product release for market expansion activities for new and modified products.
• Maintaining a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices, and medical terminology.
• Planning, leading, and supporting internal and regulatory agency audits.
• Leading and directing engagement with regulatory authorities as required.
• Initiating and managing regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact on domestic and international product registrations, updating registrations as required.
• Developing and maintaining company Standard Operating Procedures (SOPs) to assure compliance with applicable global regulatory requirements.
• Providing technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
• Reviewing product labeling to ensure compliance with regulatory requirements.
• Performing other activities as assigned.

Qualifications

• Experience in regulatory affairs, particularly with medical devices.
• Strong understanding of global regulatory requirements.
• Excellent communication and project management skills.

Requirements

• Ability to work independently and as part of a team.
• Proficiency in preparing regulatory submissions.
• Experience with regulatory audits and compliance.

Benefits

• Competitive compensation.
• Comprehensive benefits including medical, dental, and vision.
• Retirement options.

Company Description

At TalentBurst, we deliver more than talent; we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long-term growth.

• Backed by precision, transparency, and results.
• Connecting top talent with leading organizations through trusted partnerships.
• Equal opportunity employer committed to an inclusive and diverse workforce.