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Manager - Regulatory Affairs – Medical Devices - Covington, Georgia - $135,000 to $180,000
Covington, GA · $135,000 to $180,000OPEN JOB: Manager - Regulatory Affairs – Medical Devices
LOCATION: Covington, Georgia
SALARY: $135,000 to $180,000
INDUSTRY: Medical Equipment / Devices
JOB CATEGORY: Legal - Regulatory / Compliance Law
IDEAL CANDIDATE:
SUMMARY:
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.
Job Responsibilities
Required Qualifications
Desired Skills and Experience
If you are interested in pursuing this opportunity, please respond back and include the following:
Upon receipt, one of our managers will contact you to discuss the position in full detail.
Stephen Fleischner
INTERMEDIA GROUP, INC.
Email: sfleischner@intermediagroup.com
LINKEDIN: https://www.linkedin.com/in/stevefleischner/
LOCATION: Covington, Georgia
SALARY: $135,000 to $180,000
INDUSTRY: Medical Equipment / Devices
JOB CATEGORY: Legal - Regulatory / Compliance Law
IDEAL CANDIDATE:
- Able to work on-site in Covington GA
- Experience with 510k & EU MDR standards
SUMMARY:
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.
Job 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.
Required Qualifications
- 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
Desired Skills and Experience
- 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.
If you are interested in pursuing this opportunity, please respond back and include the following:
- MS WORD Resume
- required compensation.
- Contact information.
- Availability
Upon receipt, one of our managers will contact you to discuss the position in full detail.
Stephen Fleischner
INTERMEDIA GROUP, INC.
Email: sfleischner@intermediagroup.com
LINKEDIN: https://www.linkedin.com/in/stevefleischner/