QA/RA Manager, Manufacturing
ProClinical is working with a global healthcare company that is seeking a QA/RA Manager to be based in Chiba, Japan on a permanent basis. This role will be a part of the company's Diagnostics Infectious Disease - Emerging Markets Business Unit, be responsible for the management of Regulatory Affairs activities and compliance.
- Develops registration plans for all company products in collaboration with regional marketing, commercial affiliates and Distributor countries marketing;
- Ensures execution of registrations of company products in alignment with regulatory plans;
- Prepares registration dossiers for CE mark, WHO Prequalification and registrations of all company products in all countries and jurisdictions according to business plans of IDEM commercial organizations.
- Represents RA in all company meetings as required and relevant.
- Reviews study protocols of other company departments for compliance with regulations as relevant to registration plans.
- Participates in audits as RA representative and main contact.
- Actively participates in short and long-range planning including the development of Key Performance Indicators;
- Manages the budget and resources of the company's regulatory activities to ensure fulfilment of the goals of the company;
- Promotes awareness of regulatory and customer requirements related to company products throughout the organisation, including through organised training programmes;
- Act as the company's site contact with the European Competent Authorities for company products carrying the CE Mark of the European Union;
- Act as site contact with the WHO Prequalification unit for company products WHO prequalified or in process to be prequalified;
- Ensures compliance with IVD Directive and IVD Regulation, US FDA requirements and WHO PQ guidances;
- Represents the company in contact with National Regulatory Agencies;
- Represents the company's RA unit at relevant leadership meetings;
- Represents the company's RA unit in relevant Industry forums;
- Supports the team in adverse event reporting;
- Supporting operations in product modification reporting;
- Gathering of regulatory intelligence related to Japanese regulations related to ARDx products;
- Upholds the company's core values.
Skills and Requirements:
- BSc or equivalent.
- Training in Regulatory Affairs.
- Relevant experience at a senior level.
- A minimum of 5 years' experience in areas directly relevant to the position
- Ability to develop and manage high performing teams to achieve desired outcomes.
- Demonstrated capacity to successfully execute strategies designed to achieve an appropriate return on investment for the business.
- Demonstrable working knowledge of the medical diagnostics industry.
- Understanding of Quality and Quality Management systems (ISO 13485, ISO 9001 and US FDA QSR)
- Knowledge of the requirements of industry regulators.
- Capacity to apply sound judgement for the effective management of the company's RA resources and personnel.
- Capacity to identify strategic opportunities and recognise threats.
- Excellent written and oral communication skills in English and an ability to prepare competent business cases.
- Strong mission orientation.
- Attention to detail.
- Strong interpersonal skills.
- Highest levels of integrity and diplomacy.
- Capacity to maintain the highest levels of confidentiality internally and externally.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Cherry Medrano on +65 3159 3197 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £60000.00 per annum
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