**Job Number**
2650640
**Business**
GE Healthcare
**Business Segment**
Healthcare Quality
**About Us**
GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
労働条件・福利厚生についてはこちらのサイトをご覧ください。
http://www.ge.com/jp/careers/benefits/healthcare
**Posted Position Title**
RA Specialist - GE Healthcare Japan
**Career Level**
Experienced
**Function**
Quality
**Function Segment**
Regulatory Affairs
Location(s) Where Opening Is Available Japan
**City**
Hino
**Postal Code**
191-8503
**Relocation Assistance**
No
**Role Summary/Purpose**
RA Specialist will be involved in Pre or Postmarket duties or both. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket and postmarket support. He/she ensures accurate and optimal submissions of regulatory reports that meet the requirements of the region or country.
**Essential Responsibilities**
• File and maintain regulatory deliverables
• Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies
• Support regulatory inspections as required
• Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and postmarket reporting through the development, maintenance and improvement of documented processes.
Premarket
• Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions
• Communicate with Product RA to establish regulatory requirements, including clinical trial data.
• Complete specific country testing and work with Product RA; arrange for test devices and support as needed.
• Provide RA oversight to clinical studies to ensure regulatory requirements are met
• Partner with Product RA to review advertising and promotion materials for country or regional compliance and approve these as required.
• Act as liaison with external regulatory reviewers to gain rapid approval of submissions.
• Work with Product RA for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license
Postmarket
• Monitor external information for incidents or issues that may involve GEHC products; communicate information internally in a timely manner.
• Liaise with relevant personnel to ensure appropriate, timely input is provided for postmarket reports.
• Review field action information to determine if reportable in local country.
• Liaise with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.
**Qualifications/Requirements**
Regulatory Affairs/薬事に関する業務知識・経験必須。
医療機器もしくは製薬/医薬品業界、関連する第三者機関での業務経験がある方、歓迎します。
1. Bachelor’s Degree (or internationally recognized equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy, Electrical Engineering, Mechanical Engineering
OR minimum of 4 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations
2. Strong analytical skills
3. Ability to work in a team environment with minimal supervision on projects and activities
4. Ability to prioritize, plan & evaluate deliverables
5. Knowledge & experience conducting scientific, regulatory, legal, or business research.
6. Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
7. Experience using spreadsheet and presentation software
8. Communication skills - Oral and technical writing skills in Japanese and English (business level).
9. Must be willing to travel up to 5% of the time
**Desired Characteristics**
1. Advanced degree in scientific, technology or legal disciplines.
2. Regulatory Affairs Certification (RAPS).
3. Experience in a medical device or pharmaceutical industry.
4. Knowledge of Quality Management Systems (QMS).
5. Experience working across cultures/countries/sites.
6. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
7. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
8. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.