Description de l'emploi
The mission of the Dosimetry team is to develop solutions to reduce the installation time of Radiotherapy centers and improve machines and patient plan verifications efficiency and accuracy.
As QA-RA Product Associate, you will ensure the implementation of the Quality Management System in compliance with applicable regulatory requirements, oversee the quality deliverables and monitors progress for final release. You will develop the quality culture across the team. You will be in charge for leading all regulatory activities within a highly regulated, fast-paced industry to ensure that Company objectives are achieved in compliance with regulatory requirements.
Duties and Responsibilities:
You will be responsible for:
- Monitor and ensure implementation of the QMS. Support its improvement
- Oversee the timely production of project's quality deliverables. Ensure QA presence on each new project.
- Review product documentation and approve pre-requisites for intermediate and final releases of products
- Train and assess training needs of staff members on quality requirements and the IBA QMS
- Support non-conformity and corrective action handling
- Meet with Regulatory Agencies/Competent Authorities to organize pre-survey deliverables and pre-survey submission strategy. Identify potential risks in submissions and anticipated regulatory responses through scenario planning.
- Compile and submit regulatory submissions to regulatory authorities and notified bodies.
- Coordinate the preparation and the delivery of reviewing responses to regulatory authorities and notified bodies. Maintain registration information (license numbers, certification declaration, etc) and obtain re-registration approvals in advance of license/certification expirations.
- Work proactively and closely with cross-functional teams on new product/feature launches according target market requirements.
- Ensure regulatory compliance with applicable standards, directives and regulations.
- Review and approve for compliance of marketing and promotional materials.
- A Master degree preferably in engineering or Science
- An experience of minimum 3 years in a Quality (QA) and/or Regulatory (RA) function is required
- Good knowledge of the regulatory aspects needed for a product release (incl. CE, FDA, CFDA, etc)
- Experience with QA in medical devices industry is a plus
- Knowledge of standards and guidelines used in medical devices (Iso 13485, IEC 60601, IEC 62304, ISO 14971, IEC 62366, etc) is a plus
- Excellent communication skills in English (written & verbal)
And you are:
- Able to demonstrate a rapid understanding of newly presented information
- Customer oriented with excellent interpersonal communication skills
- A team player able to work transversally in international environment
- Able to organize your work autonomously according to priorities
- Fascinated by new technologies and always willing to update your knowledge
公司The fastest and most accurate Dosimetry solutions.
We are the global #1 solution provider of quality assurance and patient safety for medical devices in cancer treatments. Our solutions enable healthcare professionals to improve the quality, efficiency and safety in medical imaging and cancer therapy. Dedication on innovations and cutting edge solutions are the basis for our double digit growth for many years. Now we are about to enter a new phase into an even brighter future. Come and join us!
IBA : opening new ways in the fight against cancer.
IBA is a cancer diagnostics and treatment company and the worldwide technology leader in the field of proton therapy. The Company’s expertise lies in the development of next generation proton therapy technologies and radiopharmaceuticals that provide oncology care providers with premium quality services and equipment, including IBA’s leading fully integrated IntegraLab® radiopharmacy system, and Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety.
Headquartered in Belgium and employing more than 1,500 people worldwide, IBA currently has installed systems across Europe and the US and is expanding into emerging markets.
The Company is focused on providing solutions in the fight against cancer.”
聘用意向书IBA offers you the opportunity to realize great achievements in the fight against cancer. Our employees are perceived as passionate, pragmatic and result oriented people dedicated to develop leading edge technologies to protect, enhance and save lives !
If you are stimulated by multicultural challenges and willing to travel, we offer you the opportunity to join a team of more than 35 nationalities working on more than 40 different sites on 3 continents.
IBA offers you a competitive performance based compensation package and a flexible work environment. You have real possibilities to evolve within IBA's worldwide, leading organization and to create your own career path, supported by training programs to acquire new skills and ensure they stay sharp.
As an Equal Opportunity Employer IBA is committed to a diverse workforce.