Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Exempt                        

Job Description : Head of Quality Assurance and Regulatory Affairs Japan

Job Function:

•        Manages and leads the day-to-day activities of the Japan QA and RA teams. 

•        Working without significant direction, provides leadership to the Company in fulfilling regulatory compliance and quality assurance by applying a thorough understanding of regulatory/standards requirements to one or more areas of expertise in regulations, pharmaceutical and medical device regulations for Japan.

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•        Provides leadership in planning and execution of Japan Regulatory strategies for new products as well as for the maintenance of existing products.

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•        Providing strategic regulatory expertise for optimum market access of the products in Japan as a member of Japan leadership team and member of Global Regulatory Affairs Leadership team.

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•        Preparing, updating, and implementing regulatory operational plans to deliver regulatory outcomes of the assigned products/projects. Provide broad operational and/or strategic support to ensure regulatory deliverables.

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•        Managing regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.

•        Lead regulatory policy shaping as required and in partnership with Government Affairs colleagues where necessary.

•        Coordinate and manage the development, implementation and monitoring of the Japan quality system.

•        Monitors the quality of products imported and ensures necessary communication and corrective actions are coordinated with the manufacturers.

•        Responsible for management of the Japan Audit and CAPA systems.

•        Exercising considerable judgment in determining approach, researches, prepares and submits required quality documents, to include those in response to documents issued by regulatory authorities.  Responsibility includes both preparation of these documents in compliance with Japanese and international regulatory authorities and providing guidance to Quality Resources staff in the preparation of same.

•        Coordinates and leads regulatory and certification inspections as well as all communications with regulatory and certification agencies. Responsibilities in this area are broad and complex with errors in judgment or failure to act having serious consequences to the business.

•        Acts as in-house consultant on quality issues. Provides constructive and relentless guidance in finding solutions to problems which are routinely of unusual complexity and which frequently affect diverse functional areas of the business.

•        Coordinates and provides technical guidance during internal audit activities.

PRINCIPAL RESPONSIBILITIES:

The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive.

• Ensure adequate resourcing and direct activities of QA/RA professionals and delegates providing support to customer management organizations worldwide. Directly responsible for managing and leading the Japan QA and RA teams.

• Establish and maintain effective and compliant quality system(s) within customer management organizations

• Establish and implement policies and procedures to ensure timely and effective product registration/regulatory submission preparation and management

• Work with Global Business Unit RA to develop Japan regulatory plan for new products and in setting standards for company promotional activities.

• Implement FC in local countries and vigilance notification after QS decision and responsible for vigilance reporting to local authorities.

• Maintain awareness and understanding of emerging or changing laws and regulations; provide timely interpretation, communication and consultation regarding new/changed requirements.

• Interact with Global Patient Safety and local PV team to support on market products.

Education:

·       Bachelor’s degree required (preferably in a related scientific discipline, business, or industrial engineering) and eight years GMP/QSR quality management experience required. Advanced degree preferred.

Experience

·       Minimum 12 years medical device industry experience. Minimum 8 years of increasing regulatory affairs responsibility in pharmaceuticals and/or medical devices

·       Submission experience with PMDA

·       Minimum of five years experience directly managing teams. 

·       Demonstrated success in effectively leading and developing teams.

·       Pharmaceutical experience is preferred.

·       Quality assurance experience is required.

Skills:

•        Ability to travel internationally 20%.

•        Must have direct experience interacting with regulatory agencies and quality system certifying bodies.

•        Must have direct experience in developing and maintaining Quality Systems.

•        Must have direct experience preparing successful regulatory submissions.

•        Should have extensive experience within Business especially in marketing, sales, service, and product support groups as well as direct experience within Quality Assurance and Regulatory Affairs.

•        Proven leadership experience to interact with senior management and must excel at building relationships and negotiating.  Must have proven success supervising and developing your people.

•        Five years of regulatory or other related experience.

•        Extensive knowledge of GMP/GQP medical device regulations.

•        Submission experience with PMDA.

•        Experience in dealing with regulatory agencies.

•        Experience managing budgets.

•        Willingness to take ownership and accept responsibility for actions and decisions.

•        Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.

•        Extensive knowledge of and ability to prepare or direct the management of Quality Systems and the preparation of quality documents.

•        Demonstrated and effective quality system management experience.

•        Demonstrated and effective leadership and managerial skills.

•        Demonstrated ability to define problems and provide guidance to top management in developing and implementing solutions.

•        Demonstrated analytical thinking skills and the ability to solve complex problems.

•        Demonstrated ability to communicate effectively both verbally and in writing.

•        Demonstrated interpersonal skills and the ability to represent the business in contacts with those both internal and external to the organization.

•        Demonstrated team oriented behavior.

•        Excellent communication and negotiating skills a must.

•        In depth knowledge of Japanese and/or international medical device regulations and standards.

•        Extensive knowledge of and ability to prepare regulatory documentation.

•        Demonstrated and effective leadership and team skills.

•        Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions.

•        Demonstrated analytical and creative thinking skills and the ability to solve complex problems.

•        Demonstrated interpersonal skills and the ability to communicate effectively both verbally and in writing.

•        Ability to work effectively with persons at all levels of the organization and to represent the organization professionally in the community.

•        Strong oral, written communication skills and sound interpersonal skills. 

•        Proven leadership ability and ability to develop teams. 

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Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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