Location: Tokyo (50% remote, 50% on-site)
Languages: English and Japanese
Start date: July 2021
Invitae is a rapidly growing medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve the quality of healthcare for billions of people.
We are a multidisciplinary company executing a novel business model in a highly technical, highly regulated, and overly complex industry against a backdrop of rapid and disruptive technological advancement. Patients are at the center of everything we do, while we continually seek to improve and grow in efficiency and strive to produce consistent and reliable results.
At Invitae, we’re building an organization that can continuously innovate at scale. Equally importantly, we’re building a company where we love to work. As a team, we pride ourselves in having a diverse group of individuals who collaborate and work well together so that we can learn and grow from one another. We rely on each other to work with a sense of urgency and with a goal of putting the team above the individual.hggt
As you join team Invitae, you are expected to help us grow and modify our culture over time, and most importantly, to challenge us when we are not living up to it. It’s important to keep in mind that we craft and maintain our culture to serve our mission, and we will adjust our culture from time to time to optimize the pursuit of that mission.
About The Role
To pursue our shared mission and help Invitae grow, we are looking for a Regulatory Affairs Specialist, APAC.
The role is based in Tokyo, Japan, and will support the APAC regulatory team through the preparation of submission documentation for IVD medical devices for submission to PMDA and other Asian health authorities as well as acting in daily duties in Japan representing Invitae’s Marketing Authorization Holder entity.
What you will do:
- Prepare draft Shonin applications and related change notifications and applications for high risk in vitro diagnostic medical diagnostics. Applications will often utilize English-language source documents prepared at Invitae’s USA-based IVD design site;
- Collaborate with regulatory affairs teammates worldwide for execution of product development plans, change management strategy and associated regulatory activities;
- Consult with USA-based product development teams on regulatory application requirements specific to Japan, China, South Korea and other Asian jurisdictions;
- Assist with reviewing Japanese product complaints for reportability to PMDA and general product safety surveillance in accordance with Good Vigilance Practice;
- Maintain proper licensing for Invitae’s Japanese Marketing Authorization Holder corporate entity in Japan, as well as appropriate foreign manufacturer and quality system licensing under PMDA regulations for Invitae’s global manufacturing sites;
- Act as a key liaison between assay technical functions and the regulatory team to ensure excellent regulatory content and consistent regulatory positioning of technical performance.
What you will need:
- University degree in engineering, technical writing, sciences, or other relevant field;
- Minimum five (5) years of experience in drafting and supporting medical device licensing and change applications to PMDA;
- One or more years of experience in monitoring and evaluating product complaints for risk level and associated reportability to health authorities;
- Strong written and spoken bilingual skills in English and Japanese for the purposes of attending frequent bilingual meetings with USA teammates and preparing Japanese documents based on English source materials;
- A strong interest in regulatory affairs and a drive to advocate for companion diagnostics and genetic sequencing clinical value with health authorities;
- Strong instincts for systems engineering incorporate multiple key attributes into a well-documented medical device platform;
- Strong working knowledge of 21 CFR 820, ISO 13485:2016, IEC 62304, risk management practices and DHF development;
- Collaborative and positive attitude.
Interested in this position? Please apply online by sending us your CV in English
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Get to know us!
Do you want to know more about us and how we are changing the genetics industry?
- Visit our website Invitae.com
- Check out Invitae’s YouTube Channel
- Follow us on Twitter, Facebook or Instagram
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