Compliance Manager

POSTED ON 11/23/2022 AVAILABLE BEFORE 3/16/2023
Compliance Insight, Inc. Hired Organization Address Cincinnati, OH Full Time

Job Posting for Compliance Manager at Compliance Insight, Inc.

Compliance Insight is actively searching for a diligent and professional Compliance Manager to join our dynamic and growing business. You will be responsible for managing and supporting a team of regulatory and quality professionals through project management and developing and mentoring consultants as they are assigned projects for our consulting business operations.

Reporting to the Associate Director, Compliance, you will perform a range of duties including evaluating all current and new compliance regulations, reviewing company processes, and leading projects. The successful candidate will be an excellent communicator, with in-depth knowledge of the latest industry procedures and regulations.

Responsibilities:

  • Manage potential projects and consultant projects (by providing Regulatory and Quality input, assisting with resolving issues, and managing timelines and costs)
  • Support and engage compliance consultants and team by:
  • Conducting initial interview with potential consultants and collaborators
  • Outreach and assignment for specific projects
  • Providing support and guidance serving as a liaison between client and company.
  • Evaluate and monitor control systems to identify and deal with discrepancies in deliverables and hours.
  • Regularly assess the efficiency of control systems and recommend effective improvements.
  • Author SOPs for the Compliance department
  • Coordinate and collaborate with different department managers to maximize, cultivate, and support client leads initiated through Business Development by leading, participating in client/potential client meetings; follow up with past clients for potential project opportunities
  • Draft, review and optimize client consulting agreements and project proposals
  • Represent company at conferences and industry sites for potential client work and relationship development
  • Lead employee training sessions on compliance issues.

Requirements:

  • Bachelor’s degree in a Life Sciences discipline, or relevant field.
  • A minimum of 15 years’ diverse experience in FDA regulated environment. Emphasis on experience with medical device and 510k submissions strongly preferred.
  • Strong knowledge of industry processes and regulations.
  • Outstanding communication and interpersonal abilities.
  • An analytical mindset with excellent organizational skills.
  • Ability to work under minimal supervision
  • Demonstrated experience working with a cross-functional team

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Ability to commute/relocate:

  • Cincinnati, OH 45246: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

  • How many years of FDA regulated industry experience do you have?
  • Do you have medical device and/or 510k submissions experience.

Work Location: One location

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