Job-ID32758545Reference26-01317Remote50% Remote Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities. The ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives. Responsibilities: Lead regulatory activities supporting product corrections, recalls, and field actions. Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions. Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting. Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes. Support internal and external audits, inspections, and compliance assessments. Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks. Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders. Provide regulatory guidance for post-market surveillance and quality-related activities. Develop and deliver regulatory compliance training to internal teams. Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle. Requirements: Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience. Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry. Minimum 2 years of direct Regulatory Affairs experience. Strong knowledge of U.S. FDA regulations and medical device regulatory requirements. Experience managing: Product Incident Reports (PIRs). Corrective and Preventive Actions (CAPAs). Product recalls and field corrective actions. Audit and inspection support activities. Experience using regulatory systems, databases, and documentation tools. Strong written and verbal communication skills.
...44064, and K0244065 Location of Employment: Multiple Locations available statewide Position/Salary and Benefits: Official Court Reporter, grade 36, $29.07 hourly ($29.81 at 6 months and $ 32.09 after one year of successful service) Kansas Judicial Branch Benefits...
...The Jewish Community Center of Louisville seeks a community relations professional to spearhead its public policy agenda, build relationships with diverse ethnic and civic groups, and advocate for Jewish causes. The ideal candidate should have an advanced degree, experience...
...Mission Multiplier is seeking a Cybersecurity Analyst, Jr. to support the execution of a... ...information systems, ensuring compliance, security, and operational readiness. This role... .... Completed coursework or additional entry-level certifications relevant to operating systems...
...migration for SIT testing in python and spark tech stack.Required Skills - ETL testing, Databricks, Strong in Cloud testingThe Test Lead/Tester evaluates the software products according to the business standards or function requirements. The Test Lead/Tester applies advanced...
...advancing cuttingedge addiction and behavioral health research as a Clinical Research Assistant. In this dynamic position,... ...skills including word processing, data entry, spreadsheet, database management, and entry level statistical/programming skills.Strong clinical...