Regulatory Affairs & Quality Specialist

PurposeThe 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 & DutiesManage Corrective and Preventative Actions (CAPAs): issue, assign, verify implementation, and ensure effectiveness within set timeframesMaintain QMS documentation and ensure proper retention of documents and recordsParticipate in activities related to adverse events and recalls, including reporting, notification, and follow-upsSupervise and coordinate external QMS auditsConduct and/or coordinate internal QMS audits to ensure compliance with legal, regulatory, and ISO standardsProvide advice and take action in response to audit findings and recommendations regarding information securityCoordinate third-party audits to assess the adequacy of controls in place to protect the organization’s informationOversee 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 documentsAnalyze and identify solutions to improve QMS efficiency; coordinate and participate in internal process improvement projectsWork on special projects related to the organization’s goals, including reports, statistics, and researchCollaborate with Privacy and Quality Managers to integrate new regulatory

Requirements

into current processesParticipate in other projects as deemed necessaryAlign cross-functional processes and update SOPsCollaborate on supplier processes and RC board managementManage EUDAMED renewals and quality plans.Required

Qualifications

3+ years of experience in quality management systemsKnowledge of ISO 13485, MDSAP, and EMDR

Requirements

Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools)Experience in the IT and/or medical device fieldCommunication & Cognitive AbilitiesProcess mapping and creationAutonomy and self-motivationStrong collaboration skillsProblem-solving abilitiesContinuous learning mindsetEffective oral and written English communication skillsPreferredBachelor’s degree in business, regulatory management, quality management, or related fieldRelevant industry training / certifications (RAPS, RAC, ASQ, CQA or similar)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.Applicants may be required to complete an online technical and/or personality 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 impairmentAt Intelerad, we believe the path to answers in healthcare should be clear-whether you are waiting for a diagnosis or trying to expedite one.

Our medical imaging solutions streamline the flow of information, simplifying complex processes, maximizing efficiencies, and shining a light on the unknown. We empower physicians to get patients the answers they need faster and improve outcomes for everyone. With more accessible imaging, we are getting patients out of the dark.

Headquartered in Raleigh, NC and Montreal, Intelerad has nearly 800 employees located in offices across four countries. The company empowers nearly 2,000 healthcare organizations around the world with the speed, scalability, and simplicity needed to increase business performance while, most importantly, improving patient outcomes. Intelerad’s modern enterprise solutions have been acknowledged by a Best in KLAS recognition, ranking #1 for PACS Asia/Oceania in the 2021 Best in KLAS: Global Software (Non-US) report.Originally posted on Himalayas