Manager, Clinical Affairs (Clinical Marketing)

OrbusNeich Medical Company Ltd.; Selangor; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading company in the medical device industry seeks a Manager for Clinical Affairs to ensure product safety and compliance. The role demands strong collaboration with engineering and regulatory teams, alongside providing clinical marketing support and overseeing clinical studies. Candidates should possess relevant degrees and a minimum of 3 years of experience in regulatory or quality affairs, ideally in cardiovascular devices.

Qualifications

• Minimum 3 years experience in regulatory or quality affairs in the medical device industry.
• Experience in cardiovascular device trials and clinical device papers.
• Fluent in written and spoken English; Mandarin preferred.

Responsibilities

• Analyse scientific literature for marketing insights.
• Author Clinical Evaluation Plans and Reports.
• Support regulatory audits and compliance.

Skills

Analytical skills

Clinical background

Team collaboration

Communication

Education

Bachelor of Science or Master’s in life sciences, biomedical engineering, or related medical field.

Job description

Job Overview

The Manager, Clinical Affairs, plays a pivotal role in ensuring that products are safe, effective and compliant with regulatory requirements throughout the product life cycle. The Clinical Affairs department will work with engineers during product development stage, Regulatory and Quality for product approval and product safety matters and sales and marketing to align global business objectives.

Responsibilities:

Clinical Marketing

• Analyse scientific literatures and provide updates to sales and marketing for better understanding of products
• Provide clinical support for marketing deck (Product Information Portfolio)
• Build and maintain relationships with medical advisors, KOLs and industry associations
• Provide training to sales and HCP with clinical data and updates

Regulatory Support

• Author Clinical Evaluation Plan and Clinical Evaluation Report
• Author Post Marketing Surveillance Plan and Post Market Clinical Follow Up
• Conduct and oversee systematic literature reviews
• Support Regulatory Affairs in reviewing Summary of Safety and Clinical Performance report and Periodic Safety Updates report in compliance with EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4.
• Support regulatory in audit and answering questions from local regulatory body
• Inform marketing when Physician Evaluation Form of a new product has been completed

Quality Support

• Support Quality department in reviewing vigilance investigations, provide input from a clinical usage perspective
• Support Quality in reviewing Risk management report/ Hazard Evaluations from a clinical safety perspective
• Support Quality in Audit and answering questions on IFU

Clinical Studies Management

• Collaborate with internal and external stakeholders to support the execution of study protocols, site selection, and clinical monitoring.
• Track study progress, ensure timely data capture, and assist in clinical data analysis and reporting.

Team Collaboration & Mentorship

• Work with team members to execute duties and provide guidance when needed
• Represent the Clinical Affairs function in cross-departmental meetings and project teams.

Requirements:

• Bachelor of Science or higher education in Master’s in life sciences, biomedical engineering, or related medical field.
• Having experience of 3 years or more in regulatory or quality affairs preferably in the medical device industry.
• Having experience in cardiovascular device trials, understand clinical device papers
• Strong clinical background, team player
• Be fluent in written and spoken English
• Preferably able to speak other languages or dialects (preferably Mandarin)