Medical Device Compliance Specialist

Jobgether; Remote; MYR 120,000 - 180,000; Full time

Job summary

A healthcare company seeks a Medical Device Quality Expert to ensure high standards for quality and compliance. This role involves leading QMS activities, developing compliance strategies, and conducting risk assessments to enhance patient safety. Candidates should have over 8 years of experience in the medical device industry, strong knowledge of regulatory standards, and the ability to collaborate across teams. The company offers competitive compensation and a collaborative work environment, along with flexible work options.

Benefits

Competitive compensation and benefits packages

Professional development and training resources

Work-life balance with flexible work options

Qualifications

• Minimum of 8 years of experience in quality assurance and regulatory compliance within the medical device industry.
• In-depth knowledge of quality standards and regulations, including ISO 13485, FDA QSR, and EU MDR.
• Experience leading quality management system implementations in a regulated environment.

Responsibilities

• Lead and oversee quality management system (QMS) activities for medical device products.
• Develop and implement quality and compliance strategies for regulatory adherence.
• Conduct risk assessments and support regulatory submissions.

Skills

Quality assurance

Regulatory compliance

Risk management

Communication

Interpersonal skills

Cross-functional leadership

Education

Bachelor's degree in engineering, life sciences, or related field

Advanced degree preferred

Job description

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Medical Device Quality Expert - REMOTE. In this role, you will play a crucial part in ensuring the highest standards for medical device quality and compliance. Your expertise will contribute to the adherence to regulatory standards and improvement of patient safety. You will collaborate with cross-functional teams to develop and implement strategies that align with industry regulations, ultimately facilitating the successful lifecycle of medical devices. Your leadership will help us to achieve compliance goals and enhance product quality, making a significant impact in the healthcare sector.

Accountabilities

• Lead and oversee quality management system (QMS) activities for medical device products throughout the product lifecycle.
• Develop and implement quality and compliance strategies to ensure adherence to regulatory requirements, standards, and guidelines (e.g., ISO 13485, FDA QSR, MDR).
• Conduct risk assessments and mitigation activities to identify and address potential quality and compliance issues.
• Provide guidance and support on regulatory submissions and interactions with regulatory agencies (e.g., FDA, notified bodies).
• Lead and support internal and external audits, including supplier audits and regulatory inspections.
• Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and other teams to ensure quality and compliance objectives are met.
• Stay abreast of emerging regulatory trends and changes affecting the medical device industry and proactively implement necessary updates to QMS processes and procedures.

Requirements

• Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
• Minimum of 8 years of experience in quality assurance and regulatory compliance within the medical device industry.
• In-depth knowledge of relevant quality standards and regulations, including ISO 13485, FDA QSR, and EU MDR.
• Experience leading quality management system implementations and maintaining compliance in a regulated environment.
• Strong understanding of risk management principles and methodologies (e.g., ISO 14971).
• Excellent communication and interpersonal skills, with the ability to effectively communicate complex regulatory requirements and concepts.
• Proven ability lead and influence cross-functional teams and drive quality and compliance initiatives to completion.
• Quality and regulatory certifications (e.g., ASQ CQE, RAC) preferred but not required.

Benefits

• Competitive compensation and benefits packages.
• Opportunity to make a meaningful impact on patient health and safety.
• Collaborative and inclusive work environment.
• Access to professional development and training resources.
• Work-life balance with flexible work options.

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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