To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

• 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.

Key Responsibilities:

• Ensure our 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.

Qualifications: 

• 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 MS Office specifically Excel, PowerPoint, and Word.

Preferred:

• 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.