Associate Regulatory Affairs / Quality Assurance Manager [Medical Device / Up to 9K]

INTEGRITY PARTNERS PTE. LTD.; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A global Medical Device MNC is seeking an experienced Associate RA/QA Manager to join their expanding team in Singapore. The successful candidate will ensure product compliance with legal and customer requirements, drive quality improvement programs, and lead regulatory submissions. Applicants should have at least 7 years of RA/QA experience and a relevant science degree.

Qualifications

• At least 7 years of RA/QA experience.
• Experience with quality management systems.
• Ability to lead interactions with regulatory authorities.

Responsibilities

• Ensure products meet legal and customer requirements.
• Drive quality improvement programs and activities.
• Maintain quality assurance policies and procedures.
• Lead the registration strategy for products/projects.
• Provide regulatory guidance for global counterparts.

Skills

Regulatory knowledge

Quality Assurance

Problem-solving

Documentation management

Education

Relevant science degree

Job description

An exciting new opportunity has come up and a global Medical Device MNC is seeking an experienced Associate RA/QA Manager to join their expanding team in Singapore. The successful incumbent will report to the Head of RA/QA.

Quality Assurance

• Ensure products delivered meet legal and customers' requirements
• Drive the quality improvement programs and activities and seek for continuous improvement.
• Deal with process quality issues; and deal with customers' quality issues & enquiries.
• Monitor GMP & QA activities of the company for regulatory compliance
• Outline quality assurance policies and procedures
• Interpret and comply with quality assurance standards
• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies
• Participates in Regulatory and Customer Audits.
• Oversee the implementation and ensure efficiency of inspection and quality systems
• Document quality assurance activities, such as internal audits
• Analyze customer grievances and other non-compliance issues
• Providing training for employees to ensure compliance with SOPs
• Analyze audit outcomes and carry out appropriate corrective procedures
• Set up and maintain pharmaceutical and medical device quality system in accordance with the company’s quality policy
• Maintain a good documentation system for organizing controlled documents and retaining records of manufacture which enable the complete history of a batch to be traced, readily available and easily traceable
• Ensure established Quality Management System such as Product Complaint & Recall, Internal &External Audits, Vendor Management, Deviation Management, CAPA, Change Control and Quality Risk Management are effectively implemented, monitored and in compliance with cGMP / authority requirements

Regulatory Affairs

• Lead the formulation of registration strategy for products/projects. Ensures effective implementation of the strategies and adhere to corporate objectives and business goals.
• Regulatory knowledge: Maintains a high level of regulatory knowledge on global/regional regulatory requirements and provides regulatory guidance for global counterparts.
• Agency interactions: Acts as core point of contact to relevant authorities/external organizations (CROs, NBs, etc) for products/projects. Liaises, negotiates and lead interactions, including appropriate documentation of the interaction, decisions and outcomes.
• Dossier submissions: independently leads the preparation, coordination or monitoring or regulatory submissions. Interacts across APAC and global to obtain and/or provide information/data for regulatory submissions.
• Coordinates change control responses from APAC countries and stock build if required with supply chain department.

You should have at least 7 years’ of RA/QA experience and a relevant science degree.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502