Collaborate with the QA manager to take lead in the QMS and ISO 13485 for the business. Manage and maintain both the MAH as well as the QMS that are align with proper compliance.
- Be part of an innovative global bio-tech company specializing in oncology
- Take lead in the QA activities to maintain MAH and QMS for the business
Be the point of contact of pharmaceutical affairs approval maintenance for company products. Be familiar with company products, development plans, market and business needs to launch effective strategies for new products in Japan but also communicate with global stakeholders to apply efficient regulatory approval.
- Be part of one of the top leading global medical device company in the industry
- Experience in RA as it is a critical area to obtain approval to launch products
To manage product release judgement, customer complaints, performing investigations with manufacturing sites, and handling in all Quality Audits.
- Top tier class II medical device company, leader in blood therapies.
- Very flat environment. Possibility of international transfer.
Responsible for managing clinical trial implementation plans and related documents
Lead negotiations with PMDA and/or physicians and other stakeholders on the progress of clinical trials, policies and other aspects of implementation from start-up to close-out of trials (including publication of results and preparation of applications for approval).
- Manage Clinical Research Projects for a Leading Oncology Diagnostics Business
- Expedite Clinical Research through Companion Diagnostics
大学病院を対象とした新規顧客・ビジネス開拓
- 最先端の医療ロボットの新規顧客・ビジネスを開拓するという面白みとやりがいがある
- スーパーフレックス制度を設けており、リモートワークを推奨している会社でライフワークバランスを保ちながら長期的に働く
Take lead in the quality responsibilities as QA officer (hinseki) for the company. Managing and investigating manufacturing sites, handling quality audits, customer complaints, in order to maintain effective regulatory compliance,
- Be part of a dynamic global medical device company with innovative products
- Take lead in the quality activities as a (hinseki) and a leading member
As a key decision maker for the Japan business within RA & QA responsibilities, take lead in the management of the department. Insuring the quality and regulatory requirements/compliance for products in the region as well as the approval for new products.
- Be part of a dynamic global medical device company with cutting edge products
- Be a key member in leadership for the regional RA & QA functions
Responsible for managing clinical trial implementation plans and related documents
Lead negotiations with PMDA and/or physicians and other stakeholders on the progress of clinical trials, policies and other aspects of implementation from start-up to close-out of trials (including publication of results and preparation of applications for approval).
- Manage Clinical Research Projects for a Leading Global Med Device Business
- Contribute to the Approval of Life-Changing Devices
- Develop and drive the implementation of Global Health Economics and Reimbursement for Japan
- Optimise the therapeutic procedures and strategies, and benchmark against best practice
- Play a leading role in developing & driving Global HEOR strategies for Japan
- Global innovative leader in their market segment
- Work collaboratively with Japan Leadership Team, GM and Global as well as the Core Diagnostics Commercial Operation Team to ensure Core Diagnostics Japan alignment with business priorities.
- Fortune 500 company who are currently ranked 86.
- High autonomy role at a industry leading diagnostics company.
- Lead partnership marketing strategies and tactics, execute downstream partnership marketing activities, and manage the marketing budget
- Collaborate closely with internal stakeholders, including Global/ APAC Partnership Marketing teams, and align partnership marketing plans and strategies to the overall business direction
- Develop & take ownership of upstream partner marketing strategies & execution
- Fortune 500 company and awarded World's Most Admired company (2022)
Take lead in regulatory responsibilities for the business with collaboration with internal/external stakeholders to obtain, maintain regulatory approval of company's products. Develop regulatory strategies and implement effective relationships with health authorities.
- Dynamic global med device doing everything in house called vertical integration
- Take lead in RA responsibilities ensuring regulatory applications for products
Take the lead in ensuring proper compliance based off the quality requirements for the business in aligned with local regulations. Be part of the QA/QMS operations in align with the PMDA Act.
- Be part of a fast growing global medical device company with class I-IV products
- Take lead in ensuring compliance with quality business requirements
Take lead in GVP/safety in the post-marketing QA of the company's products. Deliver and input complaint handling, corrective actions, field actions, when necessary.
- Join a dynamic global biomedical equipment company with 1st in class products
- Take lead in post-marketing QA in safety to deliver effective quality
Lead in the safety activities and management of the GVP/PMS team under PMDA regulations. Comply with GVP requirements as well as compliance in quality standards based on global quality systems.
- Be part of a globally renown med device company from Class I-IV products
- Lead the GVP/PMS team where all decisions are being made in Japan for APAC
Take lead in safety of medical products in accordance to PMDA. Be the point of contact for local and global stakeholders to provide effective information, complaint handling, dynamic GVP systems.
- Be part of an innovative medical focused organization for various unmet needs
- Lead the GVP operations for product safety for effective 1st class results
One of the largest dental solution companies is looking for a dynamic Service Operation Director, leading a large group of service engineers, taking care of the repair operation of the client machinery.
- World Largest dental solution company.
- Possibility to lead a multidisciplinary team in a highly profitable company.
Ensure effective quality management systems and compliance is in line with customer as well as regulatory standards. Be part of the growing business to introduce new and innovative products.
- Be part of a top leading biotech business that is growing exponentially
- Take lead in QMS and compliance function to provide effective high standards
Lead the design strategies within QA and plan risk management for company's products. Communicate with external manufacturers to improve QA capabilities.
- Be part of a growing biotech business with cutting edge and dynamic products
- Lead QA responsibilities in risk management, establishing QMS, and compliance
- Engage customers by selling diagnostic reagents products, identify customer needs and help find solutions through introducing assigned products .
- Support current, and existing products. Maintain customer relationships by acting as first line liaison.
- Utilize your sales experience in Life Science industry
- Global Life Science company with great product pipelines.
