Regulatory Affairs Specialist II

A valued and tenured Class III Medical Device Client of our is looking to bring on a Regulatory Affairs Specailist II to join their tenured team! This is a growth position and you will be apart of a tenured team who have been there for over 5+ years and an organization that promots internally. Here you will be responsible for US and CANADA submissions along with working with the global team on other regulatory functions.

• Prepare regulatory submissions including PMA supplements
  , EC marking applications
  , and global product registrations to support commercial distribution.
• Provide regulatory guidance to cross‑functional teams, reviewing documentation for compliance under the direction of senior RA staff.
• Review product and manufacturing changes to ensure alignment with applicable regulations and standards.
• Assess supplier change notifications and coordinate with internal stakeholders to determine regulatory impact and required actions.

• Support responses to regulatory authority inquiries; may participate in meetings as an observer.
• Assist in maintaining and improving departmental procedures, tools, and best practices.
• Support company initiatives to meet new and existing global regulatory requirements and international standards.
• Participate in regulatory audits as needed.

• Build and foster relationships across business units and functional groups.
• Contribute to shared knowledge and best practices that strengthen the organization's regulatory capabilities.

• Bachelor's degree in a scientific or engineering discipline required;
  Master's preferred.
• 2-3 years of regulatory affairs experience in the medical device industry (Class II or III required).
• Working knowledge of FDA and EU MDR regulatory requirements; experience with implantable devices is a plus.
• Strong technical writing skills with experience preparing regulatory submissions.
• Ability to manage multiple priorities in a fast‑paced, matrixed environment.
• Excellent communication, analytical, and problem‑solving skills.
• Proficiency in English required; additional languages a plus.

APPLY NOW FOR IMMEDIATE CONSIDERATION!

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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