Compliance Specialist 2 Maxonic
Overview
Maxonic seeks a Compliance Specialist 2 to coordinate field action team activities ensuring proper processing of customer acknowledgement forms and inquiries. This role involves collaboration with business partners and management to address customer escalations while supporting quality initiatives. The specialist will maintain record retention and provide updates on field action effectiveness.
What You'll Do11
- 1Process and reconcile customer returned acknowledgement forms per regulations and internal procedures
- 2Provide guidance to customers regarding product recall related questions
- 3Assist in preparing monthly regulatory reports on field action effectiveness status
- 4Manage the recalls inbox and complete requests as needed
- 5Support status updates to cross-functional teams when required
- 6Deliver information to Audit Management on maintaining audit readiness for internal and external audits
- 7Perform assessments and develop action plans to manage recall inbox and address urgent communications
- 8Collaborate in developing and improving processes within the quality management system
- 9Prepare monthly regulatory reports on field action effectiveness status
- 10Coordinate with field action team to ensure effective handling of customer inquiries
- 11Drive plan to effectively manage recall inbox and respond appropriately to communications
Requirements11
- 1Minimum Bachelor Degree – BS degree in Engineering Physical or Biological Science or other technical field
- 24 plus years experience in product quality or regulatory compliance in medical device or regulated industry
- 3General understanding of applicable US medical device regulations such as 21 CFR Part 820 and 21 CFR Part 11
- 4International standards including ISO 13485 and ISO 14971
- 5Experience with computer regulations and methodologies
- 6Strong organizational written and verbal communication skills
- 7Critical thinking abilities and proficiency in constructive dialogue
- 8Ability to prioritize tasks in a fast-paced dynamic environment
- 9Experience working directly with FDA Notified Bodies or other governmental agencies
- 10Commitment to finding positions meeting long-term career needs of candidates
- 11Dedication to award-winning recruiting specialization and client relationships
Salary Insight
$100k per year
Location
Required Skills
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