What are the responsibilities and job description for the Regulatory Affairs Project Leader position at Mindlane?
Position Details:
Role: Regulatory Affairs Project Leader
Location: Hybrid Maple Grove/St. Paul, MN
Duration: 6 months with potential extension or likely FTE conversion
Job Description:
Hours: 8:00am-5:00 PM
Location: Local to the Maple Grove MN or St Paul MN area- Could potentially be a Hybrid role; however, if converted, it will be 4-5 days per week onsite.
Duration: This is a 6-month contract with potential to extend or convert highly likely
Overview:
The Global Regulatory Services (GRS) Quality Compliance Project Lead is responsible for supporting the RA procedure harmonization and related maintenance activities post harmonization.
Regulatory processes have been harmonized across 6 medical device business units
Support GRS owned CAPA activities related to RA procedural changes.
These activities include managing GRS CAPA tracker, quality review for verification, lead CAPA correction and corrective action delegated activities and tasks.
TOP 5 Desired qualifications and experience:
1. Procedural Writing
2. CAPA Expertise
3. Project management skills organize and lead meetings for procedural development
4. 5 years experience in a regulated industry
5. Familiarity with Regulatory Affairs departmental responsibilities and processes
Desired Qualifications
Bachelors Degree
Quality Systems experience desired
Must understand regulatory processes and be quality system oriented and have a background in both areas
Technical writing skills
Strong communication skills (written and verbal)
Proven success managing multiple projects and priorities
High Attention to detail
Proficient in Microsoft Word, Visio, and PowerPoint
Windchill experience a Plus but not required
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
