Regulatory Affairs Manager Jobs

The Position

• Accountable for establishing and ensuring recall processes adhere to global regulations and internal procedures. Ensures corrections, removals and recalls are managed effectively and efficiently including ensuring regulatory compliance and technical accuracy for all necessary recall documentation (i.e. 21 CFR 806, Urgent Medical Device Correction, Field Safety Corrective Action, etc.
• Leads and manages the Medical Device Vigilance program, including but not limited to, ensuring potentially reportable incident/potential safety incident criteria is maintained/updated at the divisional level.
• Leads and manages the global adverse event reporting (AER) program, including but not limited to, Medical Device Reporting assessments and submissions, Manufacturer Incident Report assessments, communications to regulatory authorities, represent Quality in Product Care Quality Teams.

• Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.•
• Supports decision making for Health Hazard Assessments, Vigilance Reporting, CAPA, and Recalls based on analysis and trending of post-market data sources.
• Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements
• Analyzes, monitors and provides trending of Recall and Adverse Event Reporting data for Quality Management Review Meeting (QMR).
• For International area ensures overall compliance with international standards and directives. Responsible for activities which lead to and maintain international regulatory approval to market devices.
• May perform other duties as required or assigned.
• Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
• Serves as Functional Lead on project team(s).
• May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer. May work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
• Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
• Other duties as assigned by management.
• Provides regulatory support on project teams.

Qualifications:

Education:

• Regulatory Affairs Certification preferred.
• B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred.

Years of Experience:

Required:

• Experience making regulatory reporting decisions associated with vigilance and filed actions
• Experience with Microsoft and Google based applications and general knowledge of PC functions necessary
• 5 years of Regulatory Affairs experience. Specific experience with IVD device experience is preferred.

Preferred:

• Experience with regulatory submissions including 510(k) submissions
• Experience developing field action processes complaint with global regulatory requirements

Knowledge, Skill and Abilities:

The expected salary range for this position based on the primary location of California is $105,000 to $195,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

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