Job Vacancy Manager Regulatory Affairs Woodlands January 2019 Newest Illumina
Information of Job Vacancy
Title of Job : Job Vacancy Manager Regulatory Affairs Woodlands Company Name : Illumina Placement : Woodlands Date : 5 months ago ---> EXPIRED ! Expired : Yes
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Here is qualifications job description that you must meet to meet Job Vacancy Manager Regulatory Affairs Woodlands 2018 Illumina which opened end of this month:
Reporting to Snr Manager, Regulatory Affairs (RA), APJ, the candidate is responsible for providing Regulatory Affairs support in the Asia Pacific Japan territory for both 's commercial and Quality Assurance operations. In addition, the position entails local RA, post-marketing and lifecycle management and quality system compliance support to Singapore’s Manufacturing site.
Tasks and Responsibilities
Responsible for Regulatory Affairs activities in Singapore particularly:
Pre-market registration of medical devices.
Develop premarket strategies for New Product Introduction (NPI) for those products developed and manufactured at Singapore. Provide regulatory insight regarding Design History File development and design control compliance.
Ensure regulatory compliance at Singapore regarding local and international regulatory legislation, standards and guidelines (e.g. HSA, EU IVDD/IVDR, FDA, MDSAP, etc.).
Manage and coordinate recalls and other field safety corrective actions in Singapore in association with local and corporate QA and RA management. In addition, initiating and managing adverse event reporting to the HSA in accordance with corporate procedures and local regulatory requirements.
Participate in change management assessments as they relate to operations, facility and product.
Ability to work with QA, R&D, Operations and other departments to identify gaps and be point of contact on regulatory matters for Singapore personnel.
Oversee Post-market Surveillance activities of registered medical devices and work with QA to provide post-market support for products manufactured at Singapore in accordance with global procedures.
Support internal, customer audit and regulatory inspections and assist QA in preparing responses to audit findings.
Support Regulatory Affairs activities in APJ, as required, particularly:
Contribute to the development of regional and/or local regulatory strategies with clear risk assessments and prudent risk taking. Makes recommendations in order to shape the regional/commercial objectives to be in line with the global strategy.
Identifies gaps that may impact implementation and translates regional/global regulatory strategies into executable local plans.
Work with regulatory colleagues to develop innovative regulatory strategies for NPIs to drive business growth; assist markets in product registration planning, claims assessment and innovation, developing registration dossiers for submission, monitoring the progress, status and timelines.
Manage product regulatory submissions as required, in close cooperation with Snr Regulatory Affairs Manager, APJ and Regulatory Affairs colleagues.
Co-ordinate, review and approve labeling, direction for use and user manuals for the region for regulatory compliance.
Monitor advertising and promotional materials for compliance with product claims as required.
Facilitate achievement of business objectives while ensuring compliant processes and practices in accordance with both regional and global regulations and requirements.
Use effective communication and influencing skills to establish and maintain open relationships with internal and external stakeholders.
Ability to quickly adapt to change and willing to learn from others. Willingness to be flexible and versatile across product categories/need states. Ability to proactively sense and quickly take action on problems and opportunities.
Provide training and updates on key regulatory legislation, systems, processes and/or projects (as appropriate).
Monitors the regulatory environment in Singapore and other APJ territories and provides assessments of the impact of new and changing regulations on the company's areas of interest and participates in driving regulatory reform in specific areas. Keep business informed in a timely manner on emerging regulatory issues and develop strategies to mitigate regulatory risks.
Preferred Educational Background:
Bachelor's degree or equivalent in science or related field required.
Preferred Experiential Background:
5+ years’ experience in the Medical Device industry and/or Life Sciences in Regulatory Affairs, particularly in Singapore. Demonstrated experience in registered devices in the EU, United States and other Asian Pacific markets would be considered an advantage.
Experience in an in vitro diagnostics device company preferred; pharmaceutical, biologics or medical device companies as alternative.
Good knowledge of Asia Pacific and global regulatory landscape that may affect 's products.
Able to work independently as well as in a team with regional offices in the APJ territory.
Demonstrated experience operating in a highly regulated environment.
Demonstrated knowledge of regulatory issues, and experience interfacing with local and international regulatory bodies, such as HSA, FDA, European competent authorities & notified bodies, MFDS, PMDA, etc.
Ability to read, analyze, and interpret governmental regulations and laboratory / test reports.
Experience with FDA QSR considered a plus
Demonstrated ability to work independently with new, complex technologies and produce professional work products.
Strong English written and verbal communication skills.
Familiarity and ability to work with office automation programs and corporate database tools.
Strong work ethic and demonstrated ability to deliver assignments on time.
Must be able to travel at least 10% of the time.
believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
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