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.


Horizontal facilitates valuable and productive conversations between you and potential employers. We can assist you in growing your career by partnering you with employers that offer challenging assignments. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $40 - $60 per hour. This is not a guarantee of compensation, as final offer amount may vary based on factors including but not limited to experience and geographic location.