Manager - Regulatory Affairs – Medical Devices - Covington, Georgia - $135,000 to $180,000

Intermedia Group•Covington, GA

2d•$135,000 - $180,000•Onsite

About The Position

The Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices . This role ensures that products meet all national and international regulatory requirements, facilitating timely market access and maintaining post-market compliance.

Requirements

Bachelor's degree in a scientific, engineering, or related field; advanced degree (Master's or Ph.D.) preferred.
Minimum of 5-7 years of experience in Regulatory Affairs within the medical device industry.
Ability to work on-site in Covington, GA

Nice To Haves

Demonstrated success in preparing and obtaining regulatory approvals (e.g., FDA 510(k), PMA, CE Mark).
In-depth knowledge of global medical device regulations (e.g., FDA regulations, MDD/MDR, Health Canada, TGA, MHLW).
Strong understanding of quality management systems (e.g., ISO 13485, 21 CFR Part 820).
Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information.
Strong analytical and problem-solving abilities, with keen attention to detail.
Ability to work independently and collaboratively in a fast-paced, dynamic environment.
RAC (Regulatory Affairs Certification) preferred.
Proficiency in Microsoft Office Suite and regulatory submission software.

Responsibilities

Develop and execute regulatory strategies for new product introductions and product lifecycle management.
Prepare, review, and submit regulatory filings (e.g., 510(k), PMA, CE Mark, etc.) to regulatory agencies worldwide.
Act as the primary liaison with regulatory agencies during pre-submission meetings, reviews, and inspections.
Interpret and apply complex regulatory requirements to product development, manufacturing, and marketing activities.
Conduct regulatory assessments for design changes, manufacturing changes, and labeling updates to determine impact and required submissions.
Manage and maintain regulatory licenses, registrations, and approvals.
Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, Marketing, and Clinical Affairs.
Monitor and analyze evolving global regulatory landscapes, assessing potential impacts on products and processes.
Participate in internal and external audits to ensure compliance with quality system regulations (e.g., ISO 13485, 21 CFR Part 820).
Develop and deliver regulatory training to internal stakeholders.