Medical Device Quality And Compliance Lead

Description:

Primary Talent Partners has a 2-year contract opening for a Medical Device Quality and Compliance Lead to join a multinational medical device company for a hybrid position operating out of Mounds View, MN.

Pay: $28/hr - $35/hr
Contract: 2 years, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship
Location: Mounds View MN, 4 days per week M-Th Core hours 9-3, expected their 8 hours to encompass those core hours.

Job Description:
In this exciting role as a Compliance Specialist on the Enterprise Field Corrective Action (FCA) Scoping Team, you will be responsible for supporting the scoping of Field Corrective Actions (FCAs) globally. Job duties specifically include reviewing bounding, scoping select FCAs, and ensuring robust FCA communication.

This position involves coordination with a diverse group of people across ***. The individual for this role will need to work independently and as a team player with the ability to use sound judgement and work through ambiguous situations utilizing peers and leadership for assistance as appropriate. The ideal candidate would have experience with Field Corrective Actions, in complying with Quality regulations, requirements, and standards in scoping of data sets.

Our Global Quality Strategy is rooted in the *** Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

Responsibilities may include the following and other duties may be assigned.

• Provides project or program support to a functional group or business process.
• Monitors project status and timetables
• Gathers and compiles information for regulatory reports
• Provides reconciliation of data to ensure all requirements/evidence is available
• Draft, coordinate review, and submit regulatory reports
• Ensure compliance of FCA files to regulations and MDT processes, identifying gaps and following up with OUs/regions/applicable owners to resolve
• Compiling final FCA file and all supporting evidence according to processes and regulations
• Ensures FCA documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements
• Identifies, leads, and implements continuous improvement projects to increase effectiveness, efficiency, and compliance.
• Ensures alignment with legal and ethical standards of the organization.
• Develops, implements, administers and certifies compliance policies, procedures, and practices.
• Provides compliance advice, investigates complaints and verifies deficiencies are corrected.
• Develops employee communication and training programs that focus on the elements of a companywide compliance program.
• Enforces anti-bribery and anti-competition laws.
• Analyzes metrics and audits functional compliance program.
• Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.

Must Have: Minimum Requirements

• Bachelor's degree and a minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience
• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.

Nice to Haves

• Knowledge of Field Corrective Actions
• Project Management experience
• Knowledge of regulatory reporting
• Must be data driven
• Ability to work in a cross-functional team environment
• Understanding of Compliance standards for medical devices