Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, DiagnosticsIndustries
Requirements
- Strong English and Japanese communication skills (written and verbal)
- Experience in Regulatory Affairs for IVD or Medical Devices (typically 2+ years preferred, but equivalent experience considered)
- Ability to collaborate effectively with cross-functional teams
- Understanding of regulatory requirements for IVD/Medical Devices
- Basic understanding of ISO 13485 and global QMS principles
- Bachelor’s degree in Life Sciences, Engineering, or related field (preferred)
- High attention to detail and strong documentation management skills
Responsibilities
- Prepare, submit, and track regulatory applications for product launches, market expansion, and registration renewals
- Evaluate the regulatory impact of product changes and coordinate actions within change control processes
- Ensure labeling compliance, including managing translations and verifying regulatory requirements
- Support interactions with regulatory authorities and Notified Bodies, responding to inquiries and submitting required documentation
- Assist with audits and inspections by providing regulatory documentation and responding to regulatory-related inquiries as a subject matter expert
- Manage adverse event reporting and ensure timely communication with relevant departments
- Monitor global regulatory changes and communicate updates with internal stakeholders
- Maintain and update documentation required for product approvals and certifications
- Conduct regulatory reviews within internal change control processes and collaborate with cross-functional teams
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the base pay or salary range for this position?
The base pay for this position is listed as N/A. In specific locations, the pay range may vary from the range posted.
Is this role remote or does it require working from a specific location?
The position is located in Japan > Matsudo-shi : 357 Nakahara, Matsuh, indicating an on-site requirement in that location.
What are the must-have skills and qualifications for this role?
Must-haves include strong English and Japanese communication skills, experience in Regulatory Affairs for IVD or Medical Devices (typically 2+ years), ability to collaborate with cross-functional teams, understanding of IVD/Medical Device regulations and ISO 13485, Bachelor’s degree in Life Sciences, Engineering or related field (preferred), and high attention to detail with strong documentation skills.
What does the team collaboration look like in this role?
The role requires close collaboration with internal teams and external stakeholders, as well as working with cross-functional teams on regulatory activities, change control processes, and audits.
What makes a strong candidate for this Regulatory Affairs Specialist position?
A strong candidate will have the must-haves like 2+ years of Regulatory Affairs experience in IVD/Medical Devices, bilingual English/Japanese skills, and ISO 13485 knowledge, plus nice-to-haves such as experience with Technical Files, international registrations, and regulatory intelligence.
Abbott
Healthcare solutions in diagnostics and devices
About Abbott
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.
Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees