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Sr RA Manager (Manufacturing) (up to 16m)
To apply regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs as a legal manufacturing site. This site will act as the legal manufacturing site for products manufactured in Japan with the aim to export to overseas markets (APAC&Europe)
Client Details
US global diagnostics kits company. Bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
Description
* Develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of product(s) or post-market change management activities into global markets.
* Oversee processes involved with obtaining and maintaining product release authorization and release of product to specified geographies.
* Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
* Provide technical leadership for site certifications and quality management system audits.
* Coordinates with cross functional teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.
Profile
* University degree.
* 6+ years experience in the Medical Device industry (ideally IVD business), with a strong focus in regulatory matters.
* People management experience.
* Fluent Japanese and business level of English.
Job Offer
* Position with a high impact in the region, collaborating with global cross multidisciplinary teams.
* Positibility to work in an environemnt that cherish diversity, with high chances of international career.
* Participating in projects with global impact, using state-of-the-art technology.
* Flexible working style and attractive salary package.
To apply online please click the 'Apply' button below.
For a confidential discussion about this role please contact Eduardo Takara on +813 6832 8678.
Client Details
US global diagnostics kits company. Bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
Description
* Develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of product(s) or post-market change management activities into global markets.
* Oversee processes involved with obtaining and maintaining product release authorization and release of product to specified geographies.
* Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
* Provide technical leadership for site certifications and quality management system audits.
* Coordinates with cross functional teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.
Profile
* University degree.
* 6+ years experience in the Medical Device industry (ideally IVD business), with a strong focus in regulatory matters.
* People management experience.
* Fluent Japanese and business level of English.
Job Offer
* Position with a high impact in the region, collaborating with global cross multidisciplinary teams.
* Positibility to work in an environemnt that cherish diversity, with high chances of international career.
* Participating in projects with global impact, using state-of-the-art technology.
* Flexible working style and attractive salary package.
To apply online please click the 'Apply' button below.
For a confidential discussion about this role please contact Eduardo Takara on +813 6832 8678.
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