Regulatory Affairs Associate
3 weeks ago
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
Tell employers what skills you have
Microsoft Office
Quality Management
Legislation
Interpersonal Skills
Regulatory Affairs
ISO
Team Spirit
MS Office
Biotechnology
Biology
Compliance
Attention to Detail
Audits
Administrative Support
Regulatory Requirements
Able To Work Independently
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