Staff Regulatory Affairs Specialist

As the Staff Regulatory Affairs Specialist, you will join a regulatory affairs team supporting a portfolio of advanced orthopedic technologies across U.S. and global markets. You will work cross-functionally to ensure products remain compliant and available in dynamic regulatory environments. This role focuses on sustaining regulatory compliance, managing post-market activities, and supporting submission strategies for modified and existing products.

What you will do

• Develop and execute regulatory strategies for post-market products to maintain market access across global regions.

• Evaluate regulatory requirements and identify submission pathways for product changes, ensuring alignment with applicable regulations.

• Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals and updates.

• Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.

• Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.

• Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.

• Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.

• Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.

What you need

Required

• Bachelor’s degree in engineering, science, or related field

• Minimum 4 years of experience in an FDA-regulated industry

• Minimum 2 years of experience in regulatory affairs

• Experience supporting regulatory submissions or compliance activities

• Knowledge of U.S. and international medical device regulations

Preferred

• Experience with Class II or Class III medical devices

• Experience authoring 510(k) submissions or equivalent regulatory filings

• Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline

• Experience interacting with regulatory agencies or supporting regulatory meetings