Senior Compliance Specialist - Mounds View, MN
6 hours ago
Job description
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We are seeking a highly skilled Senior Compliance Specialist to join our team, where you will play a crucial role in managing our Field Corrective Action (FCA) portfolio. This position offers the opportunity to work in a dynamic environment, ensuring compliance and quality documentation in the medical device industry.
Responsibilities
- Maintain and update documentation for active FCAs, ensuring accuracy and completeness.
- Monitor open tasks related to FCA execution, proactively following up with responsible parties.
- Prepare materials and support both internal and external audits related to FCA processes.
- Identify opportunities to streamline FCA documentation and tracking processes.
- Collaborate with cross-functional teams to ensure FCA activities align with business and compliance requirements.
- Ensure FCA activities comply with relevant regulations and internal standard operating procedures.
<>Skills
- Bachelor's degree in a relevant field such as Life Sciences, Engineering, or Business.
- Minimum of 4 years of experience in the medical device or pharmaceutical industry.
- Strong project management and organizational skills with the ability to manage multiple priorities.
- Excellent written and verbal communication skills.
- Ability to work independently and deliver results with minimal supervision.
<>Preferred Skills
- Experience managing or supporting Field Corrective Actions (FCA) or similar post-market activities.
- Familiarity with audit processes, whether internal, external, or regulatory.
- In-depth knowledge of industry regulations, including FDA and ISO standards.
- Advanced proficiency in documentation and tracking tools like SharePoint and Excel.
At our organization, we believe in fostering a culture of diversity, equity, and inclusion. We welcome applicants from all backgrounds and experiences to ensure a rich and diverse workplace.
By applying for this position, you acknowledge and agree that Horizontal Talent may contact you regarding your application using automated technology, including phone calls, SMS/text messages, or email, which may be delivered by our virtual AI recruiter, Alex. Consent is not a condition of employment, and you may opt out of SMS communications at any time by replying STOP.
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