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Senior Technical Compliance Manager

2 months ago

Santa Ana, California, United States Irvine Scientific Full time

We are seeking a Senior Technical Compliance Manager.

The Senior Technical Compliance Manager will oversee and ensure that product adherence aligns with standard operating procedures (SOPs) and regulatory/quality assurance (RA/QA) requirements. This role encompasses responsibilities related to customer feedback, corrective and preventive actions (CAPA), quality strategy, and facility modification requests (FCRs).

Engage in the processes surrounding customer feedback and inquiries, which includes but is not limited to, the intake of complaints, documentation, leading assigned investigations, customer follow-up and management, as well as tracking, analyzing, and reporting on the management and activities of the Technical Investigations Program.

Serve as the principal investigator for customer inquiries, complaints, and/or CAPA investigations, as designated, with assistance from cross-functional teams, while maintaining direct communication with customers.


Key Responsibilities:
Ensure prompt resolution and documentation of customer inquiries.

This involves delivering timely and precise solutions to customers' technical challenges, troubleshooting issues, and addressing any concerns raised by customers.

Collaborate effectively with internal teams, including customer support, sales, field application specialists, and research and development, to provide efficient and effective resolutions to customer inquiries.

Additionally, it is essential to uphold the company's reputation as a technical authority and industry leader by playing a pivotal role in fostering this recognition among customers.

Drive ongoing enhancements for metrics related to productivity, customer satisfaction, and overall customer engagement.

Lead initiatives, with support from cross-functional teams, to implement solutions for product issues or positioning, ensuring that timelines are adhered to and customer satisfaction is prioritized.

Oversee product compliance activities, which include, but are not limited to, the initiation, closure, and investigation support of assigned CAPA owners.

Review and strategize for Facility Change Requests (FCR).
Document writing, review, and closure of Quality Planning Activities across all sites.
Manage compliant documentation intake, investigation oversight, complaint review and approval, customer follow-up and communication, as well as tracking, analyzing, and reporting on the program.

Assess the nature of direct and indirect customer inquiries, categorizing them for resolution.
Lead and monitor customer inquiries associated with complaints or CAPAs. Assist in coordinating cross-functional activities for compliance initiatives.

Ensure timely and accurate closure of customer complaints, CAPAs, FCRs, and Quality Planning activities, meeting established turnaround times.

Guarantee compliance with processes and procedures to applicable standards related to compliance activities, including but not limited to, complaints, CAPAs, FCRs, and Quality Planning.

Assist in communication with regulatory agencies, notified bodies, and competent authorities as related to compliance activities.
Revise or create Technical Support SOPs based on feedback and data, as necessary.

Required Qualifications:
A Bachelor's Degree with a minimum of 4 years of relevant experience in the medical device or related industry. Advanced degrees (Masters or PhD) are preferred and may contribute to experience.

A minimum of five (5) years of experience in Technical Support or Customer Service and/or Quality Assurance/Regulatory Affairs/Compliance, with a focus on technical and customer support in a medical device context.

Familiarity with quality control methodologies, QA control systems, and production methodologies.
Experience in ART, Cytogenetics, and cell and tissue cultures. Experience may be derived from education or industry.
Ability to secure cooperation from other groups and act as a principal in cross-functional teams.
Experience with risk management and Failure Mode Effects Analysis (FMEA).
Strong root cause analysis skills are essential.
Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
Knowledge in Mammalian Cell & Tissue Culture; Biochemistry is preferred.
Leadership and decision-making capabilities.
Effective communication and presentation skills.
Proficiency in English, both written and spoken, is required.
Additional language skills are advantageous.

Compensation and Benefits:
The base salary range for this position is competitive and will be determined based on various factors, including qualifications, education, prior experience, and location.

Irvine Scientific is an equal opportunity employer, committed to diversity and inclusion in the workplace, and does not discriminate based on age, ancestry, color, disability (mental and physical), gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), sexual orientation, or any other status protected by federal, state, or local law.