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Regulatory Affairs Specialist (Medical Devices)

Keywords / Skills : Regulatory Affairs Specialist (Medical Devices)

3 - 8 years
Posted: 2019-01-10

Nationality
Singapore
Industry
Recruitment/Staffing/RPO
Function
Pharmaceutical/ Biotechnology
Role
Regulatory Affairs Executive
Education
Bachelors
Degree
Posted On
10th Jan 2019
Job Ref code
9083
Job Description
  • Global renowned medical devices company with more than 100 offices worldwide
  • Great company culture with good benefits
  • Located in the west of Singapore

A global renowned medical devices MNC is looking for highly motivated, resilient and meticulous regulatory affairs specialist to join their team. You will be responsible for submissions for new products, variations and renewals. You will be interacting frequently with internal and external stakeholders to develop regulatory strategies and to provide timely updates.

Responsibilities
  • Compile dossiers for preparation of submissions and renewals in a timely manner for Singapore and ASEAN countries.
  • Develops and provides regulatory advice for developing products
  • Work closely with various teams (marketing/ supply chain/ manufacturing) to obtain timely regulatory approvals and stock management
  • Monitor changes in the global regulatory framework in order to develop and implement regulatory strategies to facilitate on-going registration activities.
  • Develop standard operating procedures, regulatory documents according to ASEAN, EU, US and other international markets regulations.
  • Liaise with relevant regulatory bodies to maintain regulatory compliance of manufacturers in Europe and Singapore.


Requirements
  • Degree holder with minimum of 3 years’ regional regulatory experience in medical devices’ space
  • Familiar with European Medical Device Directive, FDA 510(k) and ASEAN markets’ regulations
  • Excellent verbal and written communication skills to facilitate clear and precise communications between different stakeholders

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).

About Company

EA Registration No. 12C5526

Founded in 1950, and established in Asia in 2004, VOLT is a NYSE listed Fortune 1000 provider of talent (recruitment), technology and consulting services with 4,200 full time employees, some 30,200 contractors and 192 offices across Europe, North and South America and Asia.

Volt's workforce solutions include executive search, contract and temporary staffing, managed services programs, vendor management systems and recruitment process outsourcing. Volt combines consultative focus, Six Sigma practices and efficient e-procurement technologies to deliver the talent and processes that help our customers succeed.
We connect companies with industry-leading specialists. Our proven search process cultivates a superior network of active and passive professionals, enabling us to provide best-fit experts in a broad range of business disciplines.

Our areas of expertise include Accountancy & Finance, Engineering, Human Resources, Information Technology & Telecommunications, Life Sciences, Procurement & Supply Chain, Property, and Sales & Marketing.
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