Global Regulatory Affairs Lead

Global Regulatory Affairs Lead

Strivector Corp is a National Recruiting and Staffing agency established in 2012 and headquartered in Austin, Texas. We are a preferred partner for several Fortune 500 companies nationwide. Strivector has been consistently rated a rare 4.6/5 on Google, Indeed and Glassdoor by our candidates, customers, employees and contractors. Elevate your professional journey with us. Strivector's premier client (a well-known market leader in their space) is hiring for the following full-time direct hire position.

Position Overview

As a Global Regulatory Affairs Lead your roles and responsibilities will include:

The client is looking for an experienced Regulatory Affairs Manager to lead regulatory strategy, submissions, and compliance activities for medical device products. This role will ensure products meet all applicable national and international regulatory requirements and support successful product launches and lifecycle management. The Regulatory Affairs Manager will work closely with cross-functional teams including R&D, Quality, Clinical, Manufacturing, and Marketing to ensure compliance with regulatory standards and timely regulatory approvals.

Key Responsibilities

• Develop and execute regulatory strategies for new product introductions and existing product lifecycle management.
• Prepare, review, and submit regulatory filings such as FDA 510(k), PMA, and CE Mark submissions.
• Serve as the primary liaison with regulatory agencies during pre-submission meetings, reviews, and regulatory inspections.
• Interpret and apply regulatory requirements to product development, manufacturing processes, and labeling activities.
• Conduct regulatory impact assessments for design changes, manufacturing updates, and labeling modifications.
• Maintain and manage regulatory licenses, approvals, and product registrations.
• Provide regulatory guidance to internal teams including R&D, Quality Assurance, Marketing, and Clinical Affairs.
• Monitor changes in global regulatory regulations and assess their impact on company products.
• Participate in internal and external audits to ensure compliance with regulatory standards and quality systems.
• Support regulatory training and awareness programs for internal stakeholders.

Qualifications

Most importantly, you need to be a passionate Global Regulatory Affairs Lead who enjoys his work and is considered to be one of the best within your organization. The ideal Global Regulatory Affairs Lead would be someone with deep experience in many (if not all) of the following:

• Bachelor's degree in Science, Engineering, Regulatory Affairs, or a related field.
• 57+ years of Regulatory Affairs experience in the medical device industry.
• Hands-on experience with FDA regulatory submissions such as 510(k).
• Strong knowledge of medical device regulatory frameworks.
• Ability to work on-site in Covington, GA.

Preferred Qualifications

• Advanced degree (Master's or PhD) in a related field.
• Experience with global regulatory submissions including EU MDR / CE Mark.
• Knowledge of Quality Management Systems including:
  • ISO 13485
  • 21 CFR Part 820
• Regulatory Affairs Certification (RAC) preferred.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional and fast-paced environment.

We understand that even if you are a seasoned Global Regulatory Affairs Lead you may not have all the skills listed here.

Compensation: Based on Experience. One of the best in the industry Minimum Education: Bachelor's degree in Science, Engineering, Regulatory Affairs, or a related field. Minimum Experience: 57+ years of Regulatory Affairs experience in the medical device industry. Type of position: Full-time Permanent position with benefits Location: Covington, Georgia Remote / Hybrid: On-site (4 days per week, Fridays remote) Relocation accepted: No