- Global fast-growing medical devices manufacturer
- Exciting company's growth plans with loads of learning opportunities
- Amazing benefits and employee's benefits
A global medical devices provider is inviting independent and meticulous regulatory affairs specialist to join their regulatory affairs team on a 12 months contract. You will be responsible to compile dossiers in preparation of submissions for new products, variations or renewals. You will be involved developing regulatory strategies to achieve approval for new products in design stage.
Responsibilities
- Write and compile technical dossiers in relation to pre-market notification submission to US FDA and CE Marking
- Involved in the development of regulatory and/or supply strategies for new products and guide NPI teams in regulatory requirements
- Liaise with various countries' regulatory affairs personnel, registration agents, distributors, sales & marketing and other relevant stakeholders, to understand and evaluate the requirements for product registrations for the designated market.
- Responsible for adverse event reporting review for complaints, AE and FSCA reporting to authority.
- Stay abreast with US, EU and Singapore regulatory guidelines.
Requirements
- Diploma/degree holder with minimum 2 years working experience in medical devices industry preferred
- Experienced with Microsoft Word and Excel
- Good communications skills in English (both oral and written) to facilitate accurate information flow between departments
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).
