Regulatory Affairs & Quality Specialist

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.

Communication & Cognitive Abilities

• Process mapping and creation.
• Autonomy and self-motivation.
• Strong collaboration skills.
• Problem-solving abilities.
• Continuous learning mindset.
• Effective communication skills – English fluency.

Note: This job description is not intended to be all-inclusive. Employee may perform other related duties as requested to meet the ongoing needs of the organization.

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.

#LI-REMOTE

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