A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
Senior Regulatory Affairs Specialist Experis•3.3 Saint Paul, MN Job Details Contract $50•$53 an hour 2 hours ago Qualifications Project team coordination Project reporting Compliance risk assessment Project documentation Spreadsheets Writing skills Bachelor's degree in business Mid-level Collaboration with product development teams Bachelor's degree in engineering Compliance documentation Schedule creation Regulatory submission editing and review Biomedical regulatory compliance Management reporting Managing projects Project risk assessment Productivity software Regulatory compliance analysis Business Project planning phase 2 years Communication skills Project stakeholder communication Cross-functional communication Progress tracking (project management tasks) Documentation reviews
Full Job Description Job Title:
Senior Regulatory Affairs Specialist Location:
1225 Old Highway 8 NW, Saint Paul, MN 55112
Duration:
6
Months Work Arrangement:
100%
Onsite Pay Range:
$50•$53 per hour (W2) We are seeking a "Senior Regulatory Affairs Specialist" to join one of our leading healthcare clients.
Position Overview :
Submission Readiness & Execution. Provide Regulatory Affairs support for multiple global submissions by coordinating submission readiness activities, tracking Regulatory Affairs deliverables, supporting compilation of submission documentation, and helping ensure key regulatory milestones are achieved. This role partners closely with Regulatory Affairs leads and project teams to maintain visibility to commitments, proactively identify risks, and support timely submission execution.
Top Skills and Experience :
Deliverable & Timeline Management, Regulatory Submission Coordination, Cross-Functional Coordination Responsibilities include : Maintain Regulatory Affairs deliverable trackers and monitor progress against established submission timelines. Conduct routine reviews of regulatory deliverables, action items, and dependencies to support submission readiness. Work closely with Regulatory Affairs leads to identify, communicate, and help address risks to planned regulatory milestones and submission dates. Collaborate with project management and cross-functional teams to ensure Regulatory Affairs activities and milestones are accurately reflected in project schedules and planning tools. Support preparation of regulatory status updates, milestone reviews, dashboards, and management communications. Coordinate Regulatory Affairs meetings supporting submission planning, review activities, and issue resolution. Assist with compilation, organization, and maintenance of regulatory documentation in accordance with established procedures. Support preliminary regulatory assessments and coordination activities associated with product, manufacturing, or labeling changes under direction of Regulatory Affairs personnel.
Years/Experience:
Minimum 2+ years of regulatory affairs experience or related medical device experience Experience supporting global regulatory submissions and registration activities Experience working within complex, cross-functional product development environments Experience utilizing project planning tools, milestone trackers, and Gantt schedules preferred Experience supporting multiple concurrent projects and managing competing priorities
Skills:
Working knowledge of medical device regulatory processes and submissions Strong organizational, communication, and follow-up skills Ability to monitor and track complex deliverables across multiple stakeholders Experience supporting preparation and review of regulatory submission documentation Strong attention to detail and problem-solving skills Ability to proactively identify risks, gaps, and timing concerns impacting regulatory deliverables Experience preparing status updates and management reports Proficiency in Microsoft Office applications, including Excel and PowerPoint Experience with project planning and tracking tools preferred
Education:
Bachelor's Degree in a scientific, engineering, regulatory affairs, business, or related discipline required We are looking for the candidate who are eligible to work with any employers without sponsorship . If you're interested, please click "Apply" button.
