Regulatory Affairs Specialist APAC

Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

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

/!\ Staffing and Recruiting Agencies /!\

Contact from Staffing and Recruitment Agencies are not appreciated and will be automatically disregarded. 

Our vacancies are only intended for individuals. 

Staffing and recruiting agencies and individuals being represented by an agency will be considered unsolicited. We do not accept unsolicited CVs or applications from agencies other than preferred suppliers. 


#LI-RM33

#LI-REMOTE

Read Full Job Description
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

Technology we use

  • Engineering
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • RubyLanguages
    • SqlLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • ReactLibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • MongoDBDatabases
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of Invitae (Formerly ArcherDx)

What’s the vibe like in the office?

Collaborative - when I walk through the Invitae office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Invitae. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

What are Invitae (Formerly ArcherDx) Perks + Benefits

Invitae (Formerly ArcherDx) Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Unconscious bias training
Diversity manifesto
Someone's primary function is managing the company’s diversity and inclusion initiatives
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Restricted work hours
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning
More Jobs at Invitae (Formerly ArcherDx)91 open jobs
All Jobs
Data + Analytics
Design + UX
Dev + Engineer
HR + Recruiting
Internships
Operations
Product
Project Mgmt
Sales
Content
Project Mgmt
new
Boulder
Developer
new
Remote
Data + Analytics
new
Remote
Project Mgmt
new
Remote
Data + Analytics
new
Remote
Developer
new
Remote
Operations
new
Remote
Data + Analytics
new
Boulder
Developer
new
Remote
HR + Recruiting
new
Remote
Operations
new
Remote
Project Mgmt
new
Remote
Operations
new
Remote
Project Mgmt
new
Boulder
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Project Mgmt
new
Remote
Operations
new
Remote
Developer
new
Remote
Developer
new
Boulder
Operations
new
Boulder
Developer
new
Boulder
Operations
new
Remote
Design + UX
new
Remote
Developer
new
Remote
Operations
new
Remote
Operations
new
Remote
Operations
new
Boulder
Operations
new
Boulder
Data + Analytics
new
Boulder
Product
new
Remote
Project Mgmt
new
Boulder
Data + Analytics
new
Boulder
Operations
new
Boulder
Content
new
Boulder
Developer
new
Boulder
Developer
new
Boulder
Project Mgmt
new
Boulder
Developer
new
Boulder
Operations
new
Remote
Project Mgmt
new
Boulder
Operations
new
Boulder
Internships
new
Boulder
HR + Recruiting
new
Remote
Developer
new
Boulder
Developer
new
Boulder
Developer
new
Boulder
Design + UX
new
Remote
Data + Analytics
new
Remote
Operations
new
Boulder