... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory ...
... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory ...
Regulatory Affairs Manager (Atlanta)
Atlanta, GA · On-site
$90 - $120/hr
... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory ...
Regulatory Affairs Manager (Atlanta)
Atlanta, GA · On-site
$90 - $120/hr
... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory ...
Practice Manager (Medical Office)
$80K - $85K/yr
A well-established boutique medical practice is seeking an experienced Practice Manager to oversee daily operations and lead a collaborative, patient-focused team. This is a great opportunity for a ...
Quick apply
Practice Manager (Medical Office)
$80K - $85K/yr
A well-established boutique medical practice is seeking an experienced Practice Manager to oversee daily operations and lead a collaborative, patient-focused team. This is a great opportunity for a ...
Practice Manager (Medical Office)
Sandy Springs, GA · On-site
$80K - $85K/yr
A well-established boutique medical practice is seeking an experienced Practice Manager to oversee daily operations and lead a collaborative, patient-focused team. This is a great opportunity for a ...
Practice Manager (Medical Office)
Sandy Springs, GA · On-site
$80K - $85K/yr
A well-established boutique medical practice is seeking an experienced Practice Manager to oversee daily operations and lead a collaborative, patient-focused team. This is a great opportunity for a ...
Practice Manager (Medical Office)
$80K - $85K/yr
A well-established boutique medical practice is seeking an experienced Practice Manager to oversee daily operations and lead a collaborative, patient-focused team. This is a great opportunity for a ...
Practice Manager (Medical Office)
$80K - $85K/yr
A well-established boutique medical practice is seeking an experienced Practice Manager to oversee daily operations and lead a collaborative, patient-focused team. This is a great opportunity for a ...
Warehouse Coordinator
Alpharetta, GA · On-site
$17.50 - $22.50/hr
... to support our medical device operations. This role is responsible for receiving, shipping ... Inventory Management: * Follow all GMP, ISO 13485, and FDA 21 CFR Part 820 guidelines and company ...
Warehouse Coordinator
Alpharetta, GA · On-site
$17.50 - $22.50/hr
... to support our medical device operations. This role is responsible for receiving, shipping ... Inventory Management: * Follow all GMP, ISO 13485, and FDA 21 CFR Part 820 guidelines and company ...
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
Senior Production Manager
Atlanta, GA · On-site
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
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Senior Production Manager
Atlanta, GA · On-site
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
Senior Production Manager
Alpharetta, GA · On-site
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
Quick apply
Senior Production Manager
Alpharetta, GA · On-site
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
... operational initiatives. Within a biotechnology and medical device environment, the Office Manager / Administrative Manager will collaborate closely with Human Resources, Finance, Regulatory Affairs ...
... operational initiatives. Within a biotechnology and medical device environment, the Office Manager / Administrative Manager will collaborate closely with Human Resources, Finance, Regulatory Affairs ...
... operational initiatives. Within a biotechnology and medical device environment, the Office Manager / Administrative Manager will collaborate closely with Human Resources, Finance, Regulatory Affairs ...
Quick apply
... operational initiatives. Within a biotechnology and medical device environment, the Office Manager / Administrative Manager will collaborate closely with Human Resources, Finance, Regulatory Affairs ...
... operational initiatives. Within a biotechnology and medical device environment, the Office Manager / Administrative Manager will collaborate closely with Human Resources, Finance, Regulatory Affairs ...
... operational initiatives. Within a biotechnology and medical device environment, the Office Manager / Administrative Manager will collaborate closely with Human Resources, Finance, Regulatory Affairs ...
Senior Production Manager
Atlanta, GA · On-site
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
Senior Production Manager
Atlanta, GA · On-site
... operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare ...
... medical device, or pharmaceutical manufacturing; IVD experience preferred. * 3+ years of experience managing or leading supply chain operations teams. * Demonstrated tenure stability, with an average ...
... medical device, or pharmaceutical manufacturing; IVD experience preferred. * 3+ years of experience managing or leading supply chain operations teams. * Demonstrated tenure stability, with an average ...
... medical device, or pharmaceutical manufacturing; IVD experience preferred. * 3+ years of experience managing or leading supply chain operations teams. * Demonstrated tenure stability, with an average ...
Quick apply
... medical device, or pharmaceutical manufacturing; IVD experience preferred. * 3+ years of experience managing or leading supply chain operations teams. * Demonstrated tenure stability, with an average ...
... medical device, or pharmaceutical manufacturing; IVD experience preferred. * 3+ years of experience managing or leading supply chain operations teams. * Demonstrated tenure stability, with an average ...
... medical device, or pharmaceutical manufacturing; IVD experience preferred. * 3+ years of experience managing or leading supply chain operations teams. * Demonstrated tenure stability, with an average ...
Quality Manager
Marietta, GA · On-site
... Operations, Engineering, Regulatory Affairs, and Service teams. The Quality Manager will serve as ... Own and maintain the company's QMS in alignment with applicable medical device standards * Develop ...
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Quality Manager
Marietta, GA · On-site
... Operations, Engineering, Regulatory Affairs, and Service teams. The Quality Manager will serve as ... Own and maintain the company's QMS in alignment with applicable medical device standards * Develop ...
Quality Manager
Marietta, GA · On-site
$110 - $150/hr
... Operations, Engineering, Regulatory Affairs, and Service teams. The Quality Manager will serve as ... Own and maintain the company's QMS in alignment with applicable medical device standards * Develop ...
Quality Manager
Marietta, GA · On-site
$110 - $150/hr
... Operations, Engineering, Regulatory Affairs, and Service teams. The Quality Manager will serve as ... Own and maintain the company's QMS in alignment with applicable medical device standards * Develop ...
Quality Manager
Marietta, GA · On-site
... Operations, Engineering, Regulatory Affairs, and Service teams. The Quality Manager will serve as ... Own and maintain the company's QMS in alignment with applicable medical device standards * Develop ...
Quality Manager
Marietta, GA · On-site
... Operations, Engineering, Regulatory Affairs, and Service teams. The Quality Manager will serve as ... Own and maintain the company's QMS in alignment with applicable medical device standards * Develop ...
Manager Medical Device Operations information
See Decatur, GA salary details
$30.3K - $38K
20% of jobs
$40K is the 25th percentile. Wages below this are outliers.
$38K - $45.8K
20% of jobs
The median wage is $51.5K / yr.
$45.8K - $53.6K
14% of jobs
$53.6K - $61.3K
9% of jobs
$61.3K - $69.1K
11% of jobs
$70.7K is the 75th percentile. Wages above this are outliers.
$69.1K - $76.9K
6% of jobs
$76.9K - $84.6K
6% of jobs
$84.6K - $92.4K
4% of jobs
$92.4K - $100.2K
3% of jobs
$100.2K - $107.9K
2% of jobs
$107.9K - $115.7K
4% of jobs
$30.3K
$62K
$115.7K
How much do manager medical device operations jobs pay per year?
As of Sep 4, 2026, the average yearly pay for manager medical device operations in Decatur, GA is $61,954.00, according to ZipRecruiter salary data. Most workers in this role earn between $40,000.00 and $75,700.00 per year, depending on experience, location, and employer.
What is a manager medical device operations?
A Manager Medical Device Operations oversees the daily activities and processes involved in manufacturing, distributing, and maintaining medical devices. They ensure that operations comply with regulatory standards, manage teams, and work to optimize efficiency, quality, and safety. This role often involves coordinating with other departments, handling audits, and implementing process improvements to meet organizational goals. They play a critical role in ensuring that medical devices reach healthcare providers and patients safely and on time.
What are the key skills and qualifications needed to thrive as a manager medical device operations?
To excel as a Manager Medical Device Operations, you need expertise in supply chain management, regulatory compliance (such as FDA and ISO standards), and operational leadership, typically supported by a bachelor’s degree in engineering, life sciences, or business. Familiarity with ERP systems, quality management software, and relevant certifications like Six Sigma or PMP are commonly required. Strong communication, problem-solving, and team leadership skills help drive cross-functional collaboration and continuous improvement. These competencies are essential for ensuring product quality, regulatory adherence, and efficient operations in a highly regulated industry.
What are some common challenges faced by a manager medical device operations, and how can they be addressed?
Managers in Medical Device Operations often face challenges such as ensuring compliance with strict regulatory standards, coordinating cross-functional teams, and managing supply chain complexities. Staying proactive with regulatory updates, fostering open communication among departments, and implementing robust quality management systems can help address these issues. Additionally, investing in staff training and process improvement initiatives can streamline operations and minimize delays or compliance risks.
What are popular job titles related to Manager Medical Device Operations jobs in Decatur, GA?
For Manager Medical Device Operations jobs in Decatur, GA, the most frequently searched job titles are:
What job categories do people searching Manager Medical Device Operations jobs in Decatur, GA look for?
The top searched job categories for Manager Medical Device Operations jobs in Decatur, GA are:
What cities near Decatur, GA are hiring for Manager Medical Device Operations jobs?
Cities near Decatur, GA with the most Manager Medical Device Operations job openings:
Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 9 hours ago
Job description
Who is CorDx?
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Type: Full time
Job Title: Regulatory Affairs Manager
Location: Onsite - Atlanta, GA
Position Summary:
The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Key Responsibilities:
Requirements
Education:
Professional Experience:
Skills & Competencies:
Benefits
Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Type: Full time
Job Title: Regulatory Affairs Manager
Location: Onsite - Atlanta, GA
Position Summary:
The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Key Responsibilities:
- Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
- Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
- Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements.
- Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products.
- Perform regulatory assessments for product changes and propose appropriate regulatory pathways.
- Maintain documentation and records of all regulatory submissions and correspondence.
- Support the preparation for regulatory agency meetings, audits, and inspections.
- Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner.
Requirements
Education:
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
- Master's degree preferred.
Professional Experience:
- 5-7 years of regulatory affairs experience within the medical device or IVD industry.
- Working knowledge of 510(k) submissions and regulatory documentation processes.
- Experience interacting with FDA and other regulatory agencies preferred.
Skills & Competencies:
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements.
- Strong organizational and project management skills with the ability to manage multiple projects and priorities.
- Excellent communication, problem-solving, and attention to detail.
- Ability to work collaboratively in cross-functional teams and manage document workflows.
Benefits
- Highly competitive compensation package.
- Comprehensive medical, dental, and vision insurance.
- 401(k) plan with generous company contributions.
- Flexible paid time off (PTO) policy.
- Additional substantial benefits.
Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
About CorDx
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Atlanta, GA, US
Year founded
2006