Regulatory Affairs Associate
1 month ago
Job Description:
Manage document control process for Quality Management Systems in compliance with ISO13485, GDPMDS and any other standards as appr..
Job Description:
- Manage document control process for Quality Management Systems in compliance with ISO13485, GDPMDS and any other standards as appropriate
- Assists in meeting the company’s objectives and sales goals by your effort in implementing smooth workflows and processes to have a highly efficient and functional sales support operation
- Develop and maintain standard operating procedures and working practices
- Prepare supporting documents for submissions to local and/or overseas health authorities for new product registration
- Responsible for regulatory and product licensing-related activities.
- Support (internal & external) audits to ensure that regulatory and quality requirements have been met
- Assist sales team in discussion with clients on regulatory matters
- Such other responsibilities as required and instructed by your superior and the management
- Ability to manage multiple simultaneous activities in a rapidly changing environment
Job Requirement:
- Bachelor’s degree or Diploma holder, preferably in Biomedical Sciences, Biology, Biochemistry, Pharmacy or Pharmacology
- Fluent English; excellent written and verbal communication skills.
- Proficient in Microsoft Office
- Good interpersonal skills to frequently work with colleagues and team members, and advise others on compliance and regulatory matters
- Excellent analytical skills Attention to detail
- Pro-active and problem-solving attitude
- Highly autonomous, yet with a profound team spirit
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