Senior Clinical Affairs Manager

OrbusNeich Medical Company Ltd.; Selangor; On-site; MYR 120,000 - 150,000; Full time

Job summary

A leading medical device company in Malaysia is seeking a Senior Manager of Clinical Affairs to oversee regulatory and quality support, manage the clinical affairs team, and ensure compliance with global regulations. The ideal candidate will have substantial experience in the medical device field and a proven track record in regulatory submissions. Strong project management and leadership skills are essential for this role.

Qualifications

• 5+ years of direct experience in clinical affairs within the medical device industry.
• Proven experience in preparing reports for Class II and/or Class III medical device submission.
• Good knowledge of FDA CFR, EU MDR, ISO 14155, and GCP regulations.

Responsibilities

• Lead, mentor, and develop clinical affairs professionals.
• Plan and execute regulatory support reports.
• Ensure all activities adhere to global regulations.

Skills

Leadership skills

Project management

Communication skills

Education

Bachelor’s degree in Life Science, Engineering, Nursing, or related field

Job description

Job Overview

We are seeking an experienced Senior Manager of Clinical Affairs to lead the planning, execution, and management of our regulatory and quality support. This role is critical for generating the reports with clinical evidence required to achieve regulatory approvals (FDA, CE Mark, etc.), support market access, and ensure post-market surveillance compliance. The ideal candidate is a leader with a deep understanding of medical device regulations, with good project management skills to lead the team and monitor timeline.

Strategic Planning & Leadership

• Lead, mentor, and develop a team of clinical affairs professionals (e.g. CRAs, Clinical Information manager).
• Plan and execute the regulatory support reports in alignment with product development and regulatory submission timelines.
• Provide clinical expertise and guidance to cross-functional teams including R&D, Regulatory Affairs, Marketing, and Quality Assurance.

Regulatory Compliance & Quality

• Ensure all clinical activities adhere to applicable global regulations (e.g., FDA 21 CFR Parts 50, 54, 56, 812; ISO 14155; EU MDR), Good Clinical Practice (GCP), and company SOPs.
• Serve as the primary clinical representative during regulatory agency interactions and audits (FDA, Notified Body, etc.).
• Work with quality on serious adverse events (SAEs) and device deficiencies, risk management ensuring timely reporting to regulatory bodies and ethics committees.

Qualifications & Experience

• Bachelor’s degree in a Life Science, Engineering, Nursing, or related field.
• Minimum of 5+ years of direct experience in clinical affairs within the medical device industry.
• Proven experience in preparing reports for Class II and/or Class III medical device submission
• Good knowledge of FDA CFR, EU MDR, ISO 14155, and GCP regulations.
• Demonstrated experience writing reports for regulatory submission documents.
• Good project management, communication, and leadership skills.
• Valid GCP certificate