Senior Manager Regulatory Affairs

Summary

Job Description Job Description

We are hiring for a Senior Regulatory Affairs Manager to join our clients organization.

Position Summary

The Senior Manager, Regulatory Affairs will provide strategic regulatory leadership supporting the development, commercialization, and lifecycle management of medical device products. This role will serve as a key regulatory partner to cross-functional teams and regulatory authorities, ensuring products meet applicable U.S. and international regulatory requirements.

The ideal candidate will have extensive medical device regulatory experience, strong knowledge of FDA and international requirements, and a proven ability to lead complex regulatory projects and mentor regulatory professionals.

Key Responsibilities

• Develop and execute comprehensive regulatory strategies for new product development, product lifecycle management, and post-market activities.
• Prepare, review, and submit regulatory applications and documentation, including 510(k)s, PMAs, technical files, dossiers, and international registrations.
• Serve as the primary regulatory contact for assigned projects and communicate directly with regulatory agencies throughout submissions, reviews, and inspections.
• Interpret and apply FDA regulations, international regulations, guidance documents, and industry standards to ensure product compliance.
• Evaluate the regulatory impact of product, manufacturing, design, and quality-system changes.
• Partner closely with R&D, Quality, Clinical, Engineering, Manufacturing, Marketing, and other cross-functional teams to achieve regulatory objectives.
• Support internal and external audits and provide regulatory guidance during inspections.
• Monitor changes to regulatory requirements and industry trends and communicate their potential impact to internal stakeholders.
• Lead and mentor regulatory affairs professionals while promoting regulatory excellence and continuous improvement.
• Manage multiple regulatory projects and priorities while maintaining timelines and submission quality.
• Maintain regulatory documentation and ensure submissions and records are accurate, complete, and compliant.

Required Qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline such as Biomedical Engineering, Biology, Chemistry, or a related field.
• 8-10+ years of Regulatory Affairs experience within the medical device industry.
• At least 3-5 years of experience in a senior, lead, or leadership capacity.
• Demonstrated experience preparing and submitting medical device regulatory applications, including 510(k), PMA, CE Mark, and/or international registrations.
• Strong working knowledge of:
• FDA medical device regulations, including applicable 21 CFR requirements
• ISO 13485
• EU Medical Device Regulation (MDR)
• International medical device regulatory requirements
• Excellent written and verbal communication skills.
• Strong analytical, organizational, and project-management capabilities.
• Ability to translate complex regulatory requirements into clear guidance for cross-functional teams.
• Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications

• Master's or Ph.D. in a relevant scientific or technical discipline.
• RAC (Regulatory Affairs Certification).
• Experience with regulatory information management systems and electronic submission tools.
• Experience interacting directly with FDA and/or international regulatory authorities.
• Experience with medical device product development, change control, and post-market surveillance.
• Previous experience mentoring or leading Regulatory Affairs professionals.

Work Environment

This position is primarily onsite in Covington, Georgia, with the flexibility to work remotely on Fridays. The role requires regular collaboration with cross-functional teams and occasional travel for regulatory meetings, audits, inspections, or other business needs.

Compensation & Benefits

• Base Salary: $150,000-$165,000
• Full benefits package

Remote work available on Fridays

Job Description

Job Description Job Description

We are hiring for a Senior Regulatory Affairs Manager to join our clients organization.

Position Summary

The Senior Manager, Regulatory Affairs will provide strategic regulatory leadership supporting the development, commercialization, and lifecycle management of medical device products. This role will serve as a key regulatory partner to cross-functional teams and regulatory authorities, ensuring products meet applicable U.S. and international regulatory requirements.

The ideal candidate will have extensive medical device regulatory experience, strong knowledge of FDA and international requirements, and a proven ability to lead complex regulatory projects and mentor regulatory professionals.

Key Responsibilities

• Develop and execute comprehensive regulatory strategies for new product development, product lifecycle management, and post-market activities.
• Prepare, review, and submit regulatory applications and documentation, including 510(k)s, PMAs, technical files, dossiers, and international registrations.
• Serve as the primary regulatory contact for assigned projects and communicate directly with regulatory agencies throughout submissions, reviews, and inspections.
• Interpret and apply FDA regulations, international regulations, guidance documents, and industry standards to ensure product compliance.
• Evaluate the regulatory impact of product, manufacturing, design, and quality-system changes.
• Partner closely with R&D, Quality, Clinical, Engineering, Manufacturing, Marketing, and other cross-functional teams to achieve regulatory objectives.
• Support internal and external audits and provide regulatory guidance during inspections.
• Monitor changes to regulatory requirements and industry trends and communicate their potential impact to internal stakeholders.
• Lead and mentor regulatory affairs professionals while promoting regulatory excellence and continuous improvement.
• Manage multiple regulatory projects and priorities while maintaining timelines and submission quality.
• Maintain regulatory documentation and ensure submissions and records are accurate, complete, and compliant.

Required Qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline such as Biomedical Engineering, Biology, Chemistry, or a related field.
• 8-10+ years of Regulatory Affairs experience within the medical device industry.
• At least 3-5 years of experience in a senior, lead, or leadership capacity.
• Demonstrated experience preparing and submitting medical device regulatory applications, including 510(k), PMA, CE Mark, and/or international registrations.
• Strong working knowledge of:
• FDA medical device regulations, including applicable 21 CFR requirements
• ISO 13485
• EU Medical Device Regulation (MDR)
• International medical device regulatory requirements
• Excellent written and verbal communication skills.
• Strong analytical, organizational, and project-management capabilities.
• Ability to translate complex regulatory requirements into clear guidance for cross-functional teams.
• Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications

• Master's or Ph.D. in a relevant scientific or technical discipline.
• RAC (Regulatory Affairs Certification).
• Experience with regulatory information management systems and electronic submission tools.
• Experience interacting directly with FDA and/or international regulatory authorities.
• Experience with medical device product development, change control, and post-market surveillance.
• Previous experience mentoring or leading Regulatory Affairs professionals.

Work Environment

This position is primarily onsite in Covington, Georgia, with the flexibility to work remotely on Fridays. The role requires regular collaboration with cross-functional teams and occasional travel for regulatory meetings, audits, inspections, or other business needs.

Compensation & Benefits

• Base Salary: $150,000-$165,000
• Full benefits package

Remote work available on Fridays