Regulatory Affairs Specialist III – Electrophysiology (on-site)

The Opportunity

We are recruiting for a Regulatory Affairs Specialist III to join our team on-site in Plymouth, MN. This new team member will support manufacturing / operations day-to-day activities for change control and provide regulatory direction on team activities.

The individual will apply basic regulatory understanding to support of product and teams as well as prepare US / CE regulatory submissions and / or registration documents for international affiliates and government agencies worldwide.

Additionally will handle regulatory activities involved in documentation, labeling, field support and apply regulatory and technical knowledge to a focused area of work assignments.

This Specialist understands, implements, and maintains the quality policy and ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

What You’ll Work On

• Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, project plans.
• Implements Division Regulatory Strategy in specific product related activities.
• Basic understanding of laws and regulations.
• Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
• Analyzes the input of cumulative product changes to current product submissions.
• Shares knowledge with others in department and on teams.
• Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
• Prepares and aligns individual goals with department goals.
• Establishes and executes against project goals and implements plans.
• Provides input to establishing group plans and implementation of those plans.
• Follows GMP guidelines and procedures.
• Writes Effectively : Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• For products division-wide : Advises and communicates to project, group, or venture regarding basic regulatory strategies.
• Signs-off at team level within delegated parameters for change control.
• Release authority for labeling / sales / promotional materials.
• Official correspondence with outside regulatory agencies are guided by supervisory staff.
• Conducts basic negotiations on routine product related issues with government agencies.
• Follows through on submission related activities to secure product approval.
• Directs own daily activities by utilizing team goals and division regulatory priorities.
• Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
• Obtains supervisory regulatory review on submission documents prior to submission to government agencies.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience
• 5 years’ work experience

Preferred Qualifications

• Bachelor’s degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.
• 5+ years’ experience in Medical Device industry
• 1-2 years of regulatory experience.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Think analytically with good problem-solving skills.
• 510(k), PMA, or other international regulatory submission experience.
• RAPS Certification.
3 days ago