Opening for Project Coordinator- Regulatory || Minneapolis, MN - Onsite || Contract & Full TIme

Job Title : Project Coordinator- Regulatory

Location: Minneapolis, MN- Onsite

Mode of Hire: Contract

Job Description:

Job Summary:

Lead and coordinate global regulatory remediation and product change activities, including Country of Origin (COO) changes, EU MDR updates, and other regulatory submissions. The role will act as the primary client-facing regulatory representative, driving regulatory impact assessments, submission strategies, dossier preparation, health authority interactions, and cross-functional stakeholder coordination. The specialist will ensure timely and compliant execution of regulatory submissions across APAC, EMEA, LATAM, and other global markets while managing project timelines, risks, and regulatory deliverables with the help of Offshore team.

Key Responsibilities:

• Product understanding & data mining of required technical documents
• Change Order Creation on Product Life cycle Management System Platform (PLM) for approval/ Certification of product
• Prepare or maintain technical files as necessary to obtain and sustain product approval
• Review documents for compliance with regulations.
• Coordinate efforts associated with the preparation of regulatory documents or submissions
• Creating country specific Documentation
• Expert Reviewer of new/revised deliverables of Technical and Design files of all the risk class medical devices for global medical device registration.
• Client interaction & Meetings
• Final Dossier submission
• Query resolution
• Standard and Regulation Gap assessment
• Tracker Maintenance
• Deficiency Responses to Notifying body / Authority body
• Lead regulatory impact assessments for product changes, including COO and manufacturing site transfers.
• Define global submission strategies and country-specific regulatory pathways.
• Create, review and approve submission packages, supporting documentation, and regulatory assessments.
• Coordinate with regional teams, business stakeholders, and project leadership.

Required Qualifications:

• Bachelor's or Master's degree in Life Sciences, Engineering (Biomedical), Pharmacy, or related field
• 7-10+ years of Medical Device Regulatory Affairs experience.
• Experience leading global regulatory submissions and product change projects.
• Strong knowledge of regulatory requirements related to manufacturing changes, EUMDR, COO changes, and post-approval submissions.
• Experience working with EU, APAC, EMEA, LATAM, and other international markets.
• Strong leadership, stakeholder management, and project coordination skills.
• Experience with Agile PLM and product change management processes.

• Knowledge about Medical device QMS such as ISO 13485 or 21 CFR 820.
• Country specific Regulation knowledge ( APAC, EMEA, LATAM & Other Region )
• Familiarity with medical device regulations such as EUMDR 2017/745
• Familiarity with process mapping tools and methodologies.
• Experience supporting project management activities in structured or regulated environments.
• Strong attention to detail and problem solving abilities.
• Ability to manage multiple tasks and priorities concurrently.
• Proficiency in standard office tools such as MS Excel, PowerPoint, and collaboration platforms.