Regulatory Affairs Specialist

Job Overview

The Regulatory Affairs Specialist plays a critical role on the Regulatory Affairs team, ensuring that all products comply continuously with relevant regulations. This role involves collaboration with cross-departmental teams and product designers to verify that products adhere to current regulatory standards and labeling requirements. A key responsibility includes managing documentation for the transition to the EU Medical Device Regulation as well as maintaining technical and risk files.

Key Duties

• Ensure product and process compliance with standards such as ISO 13485, FDA Quality System Regulations, Medical Device Directive (MDD), Transportable Pressure Equipment Directive (TPED), and Medical Device Single Audit Program (MDSAP) by reviewing and approving Engineering Change Orders for design control compliance.
• Lead the transition efforts from MDD to the Medical Device Regulation (MDR) and from CE to UKAS certification by preparing necessary documentation including technical files and reports.
• Collaborate with Engineering during new product introductions and modifications to create Regulatory Plans covering testing, approvals, labeling, and post-market surveillance.
• Support audits conducted by third parties, notified bodies, and regulatory authorities, and participate as needed on the internal audit team.
• Oversee complaint file management and facilitate transferring this responsibility to the Quality department.
• Train as a MasterControl system power user with administrative rights to assist the MasterControl team as backup.
• Take leadership roles in Regulatory team meetings and undertake additional regulatory projects and assignments as required.

Work Environment & Physical Requirements

The position is primarily office-based within a professional and manufacturing/distribution setting located in Canton/Ball Ground, Georgia, approximately 30 minutes from Atlanta. The job is mostly sedentary but may require occasional lifting, bending, or standing. Travel is expected up to 10%, which may include international trips.

Qualifications

• Bachelor’s degree from a four-year university, preferably in engineering or a technical discipline.
• At least three years of experience in regulatory affairs or a related field.
• Familiarity with regulations and standards including ISO 13485, FDA QSR, MDD, MDSAP.
• Working knowledge of the EU Medical Device Regulation (2017/745).
• Strong verbal and written communication abilities across organizational levels.
• Proven experience working effectively in cross-functional teams and managing projects.
• Ability to handle multiple tasks and projects simultaneously with organized planning skills.

Preferred Qualifications

• Master’s degree or MBA.
• Relevant certifications aligned with regulatory affairs.
• Experience in FDA 510(k) submissions.
• Knowledge of international product approval processes.

Additional Information

This job description is not exhaustive and may be updated as necessary without prior notice. The company is an equal opportunity employer committed to diversity and prohibits discrimination based on race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or legally protected classes.