Regulatory Affairs Team Lead
- Kamunting, Perak
- Permanent
- Full-time
2. Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
3. Support the organization in change control activities for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate.
4. Support regulatory agency and/or notified body audits by as needed.
5. Participate in development and approval of risk activities as well as other deliverables as related to projects.
6. Review and approve Clinical Evaluation, PMCF, SSCP development and updates to achieve regulatory compliance.
7. Provide regulatory input to product lifecycle planning.
8. Support regulatory tasks and strategic initiatives, and recommend solutions to address potential regulatory and quality issues.
9. Review and approval of all labeling (product, advertising and promotional), considering potential regulatory impact, and clinical evaluations.
10. Support CAPAs, NCs, and other quality efforts, as needed.
11. Assist in regulatory due diligence process, as needed.
12. Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
13. Monitor impact of evolving global regulations regarding submissions, practices, and procedures and to regulatory processes and internal stakeholders.
14. Support RA Manager with other regulatory tasks and initiatives. Propose solutions for Regulatory Affairs questions/issues to RA management, as necessary
15. Oversee product registration, tender and license applications.
16. Prepares monthly reports to RA management
17. Adhere to Code of Ethics for Regulatory professionals.
18. Comply with Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
19. Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirementsEducation / Experience Requirements
- A Bachelor's Degree in Science or Engineering field is preferred. Bachelor's degrees in other disciplines may be acceptable with equivalent experience.
- 2-5 years of experience in medical device and regulatory affairs or equivalent experience
- Must be able to demonstrate strong experience with technical files/design dossiers, global regulatory submissions i.e. MDR, 510(k), Health Canada licenses, and other international submission requirements.
- Must have experience with all aspects of design controls
- Working knowledge of Quality Assurance/ Quality Engineering is preferred
- Strong communication skills
- Strong attention to detail & analytical thinking skills
- Strong ability to apply technical solutions to problem solving
- Strong interpersonal, technical writing and organizational skills
- Ability to prioritize and manage multiple projects to meet deadlines with minimal oversight
- Ability to analyze and resolve non-routine regulatory issues using independent judgement
- Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality
- Ability to comply with business and Regulatory Affairs ethical standards.
- Proficient in Microsoft Word, Excel, Power Point, and Outlook required
- Knowledge of electronic document management systems
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