Regulatory Affairs Associate, Product Management

Teleflex; Kamunting; On-site; MYR 60,000 - 90,000; Full time

Job summary

Teleflex seeks a Regulatory Affairs Associate to join Global Operations. The role focuses on generating and maintaining regulatory submissions to FDA, EU NB, and Health Canada, with support for license applications and amendments.

You will collaborate with regional teams to register products internationally and ensure compliance across labeling and documentation. The ideal candidate holds a science or engineering degree and demonstrates strong communication, organization, and regulatory

Qualifications

• Bachelor’s degree in science or engineering or equivalent experience.
• Knowledge of regulatory submission processes and documentation.
• Ability to interact professionally with diverse teams and regulators.
• Proven organizational and time management skills.
• Strong communication and analytical abilities are required.

Responsibilities

• Generate and maintain Technical Files and regulatory submissions to FDA, EU NB, Health Canada.
• Assist with license applications and amendments and compile supporting documents.
• Support change control activities and product development for regulatory impact.
• Coordinate with Regional RA for registration of products in foreign markets.
• Support Health Canada licenses renewals and FDA listings under supervision.
• Review labeling for regulatory impact and ensure compliance with guidelines.
• Identify risk factors and prepare regulatory assessments for projects.
• Monitor evolving global regulations affecting submissions and processes.
• Update regulatory databases and assist in product registrations and tenders.

Skills

Confidentiality

Communication

Analytical thinking

Time management

Multitasking

Regulatory knowledge

Education

Bachelor’s degree in science or engineering

Tools

Microsoft Office

Word

PowerPoint

Excel

Outlook

Teams

Job description

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Regulatory Affairs Associate, Product Management

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. Generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada under supervision. Responsible for ensuring the files are in compliance with relevant regulations and standards.
2. Assist in regulatory submissions, license applications and amendments (e.g., 510(k), EU MDR, Health Canada) by compiling documents and performing administrative tasks.
3. Support the organization in change control activities/ product development for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate.
4. Communicate with Regional RA to ensure timely notification of changes as appropriate. Partner with Regional RA to support registration of product in foreign markets. Fulfill basic requests and coordinate with applicable RA staff regarding more complex requests.
5. Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment registrations, inspections, audits, etc under supervision
6. Review and provide feedback to risk management assessments and design control deliverables, as necessary to ensure that it follows the regulatory requirements under supervision.
7. Identify risk factors and contingency planning for assigned projects and communicate to RA management as appropriate
8. Review and approve all labeling (product, advertising and promotional) verbiage and evaluate for regulatory impact under supervision
9. Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
10. Apply understanding of the quality systems to job activities and projects by adherence to established and evolving internal requirements.
11. Brings Regulatory Affairs questions/issues to the attention of RA management and support identification of process improvements for regulatory affairs activities.
12. Monitor impact of evolving global regulations regarding submissions, practices, and procedures to regulatory processes.
13. Support product registration, tender, license applications and maintain regulatory database as appropriate.
14. Coordinate regulatory impact assessments for projects. Communicate the impact and support required for regulatory activities.
15. Update and maintain market authorization, execute SAP ship control transactions to release, hold, or end product commercialization for the US and Canadian regions
16. Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
17. Support departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
18. Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements
19. Other duties as assigned by the Regulatory Affairs management team

Education / Experience Requirements

Education/ Experience Requirements:

• Bachelor’s degree in a science or engineering field (or equivalent experience).

Competency

Competency:

• High degree of confidentiality and professionalism.
• Excellent oral and written communication skills with a demonstrated ability to interact effectively with individuals at all levels in the organization.
• Strong analytical and critical thinking skills.
• Strong verbal and writing communication skills.
• Strong organizational and time management stills.
• Ability to manage multiple projects and meet deadlines.
• Ability to comply with business and Regulatory Affairs ethical standards.
• Proficient in Microsoft Office with emphasis on Word, PowerPoint, Excel, Teams and Outlook.

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.