Regulatory Affairs Specialist

Teleflex; Kampung Jentz Settlement; On-site; MYR 60,000 - 80,000; Full time

Job summary

A global healthcare company is seeking a regulatory professional to oversee the preparation of product registration documents and ensure compliance with medical regulations. The ideal candidate will hold a Bachelor's degree in Engineering and have at least 2 years of experience in the medical device industry. Responsibilities include reviewing technical data, preparing regulatory strategies, and ensuring compliance with FDA and international regulations.

Qualifications

• Minimum 2 years of experience in quality systems or regulatory in the medical device industry.
• Experience preparing product registration documents and submissions.

Responsibilities

• Oversee preparation of product registration documents.
• Review and evaluate technical data for regulatory submissions.
• Prepare regulatory strategies for various projects.
• Ensure product labeling compliance with regulations.

Skills

Regulatory strategy preparation

Technical data evaluation

Compliance with FDA regulations

Quality system experience

Education

Bachelor’s Degree in Engineering or equivalent

Job description

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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

1. Overseeing preparation of product registration documents and product tender applications for submission to global product registration groups.
2. Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to the US-FDA, EU-NB, Health Canada and other foreign regulatory agencies.
3. Review and evaluate change impact on US 510(k), license in Health Canada, MDD Technical File, and product registration in various countries. Prepare regulatory strategy.
4. Review transfer product project impact on 510(k), license in Health Canada, MDD Technical File, and product registered in various countries for transfer products. Prepare regulatory strategy.
5. Review and approve product labelling to ensure compliance to US-FDA, EU-MDD, Health Canada and other foreign regulatory agencies, and UDI requirements.
6. Apply for new Health Canada license and amend existing licenses as requested.
7. Maintenance of updated and revised standards to support compliance of Teleflex Medical product.
8. Participate in R&D projects, changes to existing products and processes and other regulatory /company projects as required. Prepare regulatory strategy.
9. Update and maintain regulatory database.
10. Review and approve marketing pieces i.e. brochures
11. Review and approval of validation protocols/reports and change requests.
12. To comply with requirements of Occupational Safety and Health Act 1994 and other legislative requirements in the workplace.

Education / Experience Requirements

Qualification :
Bachelor’s Degree in Engineering or equivalent

Experience :
Minimum 2 years Quality System or Regulatory experience in medical device industry.

Specialized Skills / Other Requirements

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Teleflex is an equal opportunities employer.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.