Regulatory Affairs & Quality Specialist
Lifelancer
Date: 5 days ago
City: Remote, Remote
Contract type: Full time
Remote
Job Title: Regulatory Affairs & Quality Specialist
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Company Description
Become part of our growing community of bright, motivated people who are dedicated and inspired by what they do best. Principled, honest, and supremely attentive are qualities that set us apart and guide our decisions, every day. Our creative approach to technology continuously breaks new ground so that our customers can do more. Solving problems and revolutionizing healthcare is the reason Intelerad was founded. For over 20 years, Intelerad has grown into a leader of the medical imaging software industry. We take pride in being a world-class healthcare solutions company with over 400 employees and over 1000 customer sites. Today, our distributed solutions play a vital role in the delivery of healthcare across 11 time zones, 3 continents, and counting.
We provide a workplace that encourages teamwork, promotes well-being, autonomy, and creativity. We are Intelerad. Join us if you care to make a difference in healthcare.
Job Description
The Regulatory Affairs Quality Specialist plays a crucial role within the Regulatory Affairs department. This position is responsible for maintaining and improving certifications such as ISO 13485, MDSAP, and CE mark, as well as ensuring compliance with other relevant standards and regulations. The Specialist collaborates with the Regulatory Affairs and Quality Manager to integrate regulatory requirements into processes and procedures, while continuously enhancing the management system. This role also involves providing guidance, support, and training to the organization.
Responsibilities Duties
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.
All applicants meeting minimum qualifications will be required to complete a 30 minute online assessment as part of your application.
Intelerad is committed to the principles of equal employment. We are committed to complying with all federal, state and local laws providing equal employment opportunities and all other employment laws and regulations. Applicants, employees and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age , disability and genetic information (including family medical history). Intelerad is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment.
Intelerad is committed to ensuring equal employment opportunity for qualified individuals with disabilities. Intelerad uses the Americans with Disabilities Act (“ADA”)as a standard for global recruiting and hiring purposes. This prohibits discrimination against qualified individuals with disabilities. The ADA defines “disability” as a physical or mental impairment that substantially limits one or more of the major life activities of an individual, a record of such impairment, or being regarded as having such an impairment
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/7aec3b4f8dfeb85c7b1e8f57beae6466
Apply on Lifelancer Platform
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Company Description
Become part of our growing community of bright, motivated people who are dedicated and inspired by what they do best. Principled, honest, and supremely attentive are qualities that set us apart and guide our decisions, every day. Our creative approach to technology continuously breaks new ground so that our customers can do more. Solving problems and revolutionizing healthcare is the reason Intelerad was founded. For over 20 years, Intelerad has grown into a leader of the medical imaging software industry. We take pride in being a world-class healthcare solutions company with over 400 employees and over 1000 customer sites. Today, our distributed solutions play a vital role in the delivery of healthcare across 11 time zones, 3 continents, and counting.
We provide a workplace that encourages teamwork, promotes well-being, autonomy, and creativity. We are Intelerad. Join us if you care to make a difference in healthcare.
Job Description
The Regulatory Affairs Quality Specialist plays a crucial role within the Regulatory Affairs department. This position is responsible for maintaining and improving certifications such as ISO 13485, MDSAP, and CE mark, as well as ensuring compliance with other relevant standards and regulations. The Specialist collaborates with the Regulatory Affairs and Quality Manager to integrate regulatory requirements into processes and procedures, while continuously enhancing the management system. This role also involves providing guidance, support, and training to the organization.
Responsibilities Duties
- Manage Corrective and Preventative Actions (CAPAs): issue, assign, verify implementation, and ensure effectiveness within set timeframes.
- Maintain QMS documentation and ensure proper retention of documents and records.
- Participate in activities related to adverse events and recalls, including reporting, notification, and follow-ups.
- Supervise and coordinate external QMS audits.
- Conduct and/or coordinate internal QMS audits to ensure compliance with legal, regulatory, and ISO standards.
- Provide advice and take action in response to audit findings and recommendations regarding information security.
- Coordinate third-party audits to assess the adequacy of controls in place to protect the organization’s information.
- Oversee and participate in the creation of QMS training materials and provide training as required. Develop RAQ education programs and training sessions.
- Participate in Quality meetings, set new metrics, and ensure existing metrics are gathered, analyzed, and acted upon. Collaborate with process owners to create, update, and review QMS documents.
- Analyze and identify solutions to improve QMS efficiency. Coordinate and participate in internal process improvement projects.
- Work on special projects related to the organization’s goals, including reports, statistics, and research.
- Collaborate with Privacy and Quality Managers to integrate new regulatory requirements into current processes.
- Participate in other projects as deemed necessary by Intelerad.
- Align cross-functional processes and update SOPs.
- Collaborate on supplier processes and RC board management.
- Manage EUDAMED renewals and quality plans.
Qualifications
- 3+ years of experience in quality management systems.
- Bachelor’s degree in business, quality management, or related field (or equivalent).
- Knowledge of ISO 13485, MDSAP, and EMDR requirements.
- Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools).
- Experience in the IT / software (SaaS) and/or medical device field (SaMD / SiMD)
- Working knowledge of common security standards such as SOC 2 and ISO 27001 preferred.
- Process mapping and creation.
- Autonomy and self-motivation.
- Strong collaboration skills.
- Problem-solving abilities.
- Continuous learning mindset.
- Effective communication skills – English fluency.
Additional Information
All your information will be kept confidential according to EEO guidelines.
All applicants meeting minimum qualifications will be required to complete a 30 minute online assessment as part of your application.
Intelerad is committed to the principles of equal employment. We are committed to complying with all federal, state and local laws providing equal employment opportunities and all other employment laws and regulations. Applicants, employees and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age , disability and genetic information (including family medical history). Intelerad is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment.
Intelerad is committed to ensuring equal employment opportunity for qualified individuals with disabilities. Intelerad uses the Americans with Disabilities Act (“ADA”)as a standard for global recruiting and hiring purposes. This prohibits discrimination against qualified individuals with disabilities. The ADA defines “disability” as a physical or mental impairment that substantially limits one or more of the major life activities of an individual, a record of such impairment, or being regarded as having such an impairment
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/7aec3b4f8dfeb85c7b1e8f57beae6466
Apply on Lifelancer Platform
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
VP of Sales (uncapped rev share)
Torre,
Remote, Remote
$100,000
-
$500,000
per year
2 days ago
Apply through the Torre link to experience the software first hand. All applicants submitted through LinkedIn will not be considered.Responsibilities & moreHi, I’m Justin Petsche, Co-Founder of Torre, VP Partnerships. Are you a recruiter looking to partner with one of the most innovate HRTech companies on the planet? Do you want to help companies fulfill roles using artificial intelligence? Our...
Remote Assistant for Marketing Communications | Part-Time
Get It - Marketing,
Remote, Remote
5 days ago
Job Title: Marketing Communications Assistant - Remote | WFHCompany OverviewJoin a dedicated team committed to creating a significant impact in the lives of individuals in need. This position provides the opportunity to leverage your skills in a meaningful way, all within a supportive and flexible work environment.Job OverviewWe are currently seeking a proactive, detail-oriented, and innovative Marketing Communications Assistant to...
Training Manager East Coast (prefer FL)
HALO Precision Diagnostics,
Remote, Remote
6 days ago
Saving Lives with Early DetectionTraining Manager (Healthcare)The mission of HALO Dx is to Save Lives with Early Detection. HALO Dx has a unique approach bringing together pioneers in the fields of radiology, molecular diagnostics and software development to create unparalleled levels of services and patient outcomes. Leveraging technology and collaborating with our own medical imaging doctors, centers and partners, we...