Regulatory and Quality Compliance Expert

Description

Primary Duties:

1. Perform all work in compliance with company quality procedures and standards.
2. Assess reportability for both global and regional events; draft initial, follow-up, and final reports; and submit appropriate forms for adverse event reporting.
3. Draft Health Hazard Assessments, field action board meeting minutes and utilize customer requirements management software to complete field action tasks.
4. Stay informed of global regulations related to vigilance reporting and field actions.
5. Advise external stakeholders on investigation requirements for vigilance reporting and field actions.
6. Represent the vigilance and/or field action function on complex, cross-functional project teams, and inform on regulatory risks.
7. Clearly communicate aspects of vigilance and/or field actions to Vigilance Operations Team (VOT) management and external team management.
8. Draft and own departmental procedures (SOPs and work instruction documents and associated templates).
9. Complete graphs and/or presentations for regular quality updates.
10. Support an environment of continuous improvement throughout the organization.
11. Manage improvement project.
12. Act as a subject matter expert during regulatory inspections and audits, as needed.

Supplemental Data:

• Ability to work well within a cross-functional team environment.
• Capable to complete work in a time-sensitive environment
• Able to begin, lead and oversee complex projects independently.

1. Performs other duties as assigned.

Training and Education:

Experience:

1. 7+ years in regulatory affairs or equivalent regulated industry employment position, medical device/IVD industry preferred
2. 4+ years leading projects

Knowledge, Skills, Abilities:

• Ability to think strategically, identify and mitigate regulatory risks and maintain regulatory compliant processes and procedures.
• Must demonstrate strong project ownership skills and peer mentorship skills.
• Personable and service oriented with attention to detail, excellent organizational and time management skills.
• Excellent written and verbal communication skills, including justification for vigilance related decisions or processes.
• Skill to work in an international company with international stakeholders.
• Comprehensive knowledge of regulations applicable to medical device/IVD industry (FDA 806 & 803, MEDDEV Vigilance, QMS requirements (QSR 820 and ISO 13485)). Must be able to interpret regulatory requirements, determine needs for maintaining compliance, and effectively communicate this information to stakeholders.

The ability to work closely with management to identify and communicate areas of technical, schedule, and budget risk.