Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, PharmaceuticalsIndustries
Requirements
- Associates Degree (± 13 years)
- Minimum 7 years of experience
Responsibilities
- Direct development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports
- Interact with regulatory agencies to expedite approval of pending registrations
- Serve as regulatory liaison throughout the product lifecycle
- Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC)
- Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products
- Serve as regulatory representative to marketing, research teams, and regulatory agencies
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the base pay for this Principal Specialist role?
The base pay for this position is listed as N/A. In specific locations, the pay range may vary from the range posted.
Where is this job located?
The position is located in Japan > Tokyo: Hamarikyu Park Side Place 9F, 17F 5-6-10, Tsukiji, Chuo-ku, with no additional locations specified.
What are the minimum qualifications for this role?
Candidates need an Associates Degree (± 13 years) and a minimum of 7 years of experience.
What experience level is expected for this Regulatory Affairs Specialist position?
This is a specialist professional individual contributor role requiring comprehensive knowledge in Regulatory Affairs, with the ability to execute highly complex projects and at least 7 years of experience.
What makes a strong candidate for this Principal Specialist role?
A strong candidate is a highly experienced resource in Regulatory Affairs with skills in directing product registration submissions, interacting with agencies, serving as a regulatory liaison, and participating in product planning, strategy, and risk management.
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