Electrophysiology (EP) Regulatory Affair Associate
One Lillehei Plaza St. Paul, MN 55117 US
The Electrophysiology (EP) Regulatory Affair Associate will work from our St Paul location support the regulatory department to ensure efficient and compliant business processes and environment. In this role, you may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. You will participate in preparing and submitting documentation needed for registration worldwide, with a focus on Latin America.
• Ensure products and procedures comply with applicable regulatory agency requirements and guidelines;
• Responsible for review Product Release activities in Windchill including maintaining accurate master data, and support any other assigned projects such as data clean up;
• Support GMP certificate and in country certificates activities;
• Work with cross-functional teams to support regulatory submission, change management and product release activities.
• Manages concurrent deadlines and meets deadlines for assigned work/tasks.
• Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures.
• BA or BS degree in health science, regulatory, business, engineering or equivalent combination of education and work experience.
• Ability to manage projects and drive them to completion with attention to detail.
• Requires ability to be innovative, resourceful, and work with minimal direction.
• Strong written and verbal communication, at all organizational levels.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Experience working in medical device industry with focuses on regulatory, or quality systems preferred.
• Strong problem-solving skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
• Skilled in Microsoft Office specifically Excel, PowerPoint, and Word.
• Fluency in Spanish and/or Portuguese desired, but not required
• Experience in regulatory affairs preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area, especially if it is in the medical device industry.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.