Job Information
Robert Half Regulatory Compliance Coordinator in Little Canada, Minnesota
Description
Are you ready to be part of a dynamic team at the forefront of ensuring global regulatory compliance within the Medical Device industry? Our client is seeking a detail-oriented and proactive Regulatory Compliance Coordinator to play a pivotal role in their Regulatory Affairs team. If you're passionate about accuracy, enjoy diving into data, and thrive in a collaborative environment where your contributions directly impact product success, then we want to hear from you!
Essential Functions:
Utilize search criteria within Windchill to retrieve regulatory approval records for assigned countries.
Download Windchill information to create Excel tracking sheets.
Validate metadata of individual approval records using Excel tracking sheets and country-specific approval record templates.
Identify and rectify discrepancies between metadata fields and approval records.
Update fields in Windchill to match approval records, including approval dates, expiration dates, models, legal manufacturer information, manufacturing facilities, and certificate numbers.
Align Windchill approval names with the GRL naming convention.
Communicate with in-country affiliates to resolve discrepancies or obtain clarification on approval records.
Notify relevant parties of expired approval records, non-compliant records, or other issues as necessary.
Requirements
Qualifications:
High school diploma required; Associates Degree preferred.
Ability to quickly learn and navigate systems, with a focus on accuracy and completeness.
Strong initiative to ensure tasks are executed accurately and efficiently.
Exceptional organizational and attention-to-detail skills.
Proficient in Microsoft Excel, including pivot tables and vlookups.
Excellent problem-solving skills and effective communication abilities.
Ability to prioritize tasks and adapt to changing priorities.
Previous experience in regulatory affairs, customer service, or business administration preferred.
Familiarity with PLM systems such as Windchill and Business Optics beneficial.
Experience with EUMDR (European Medical Device Regulations) desirable.
Project management and customer service skills preferred.
Flexible to work both independently and collaboratively within a team environment.
Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
© 2024 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https:///www.roberthalf.com/us/en/terms) .