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
Life Sciences, Regulatory AffairsIndustries
Requirements
- Bachelor's or Master’s degree or equivalent and relevant formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Good knowledge of RIMS documents management
- Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines
Responsibilities
- Supports the preparation of documentation and submissions under EUCTR guidance
- Coordinates and manages client deliverables supporting regulatory compliance
- Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects
- Evaluates client needs in relationship to overall project timelines, quality and delivery
- Engages with other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed
- Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients
- Supports preparation of bids and proposals; generates, tracks and analyses data for proposal, revisions, contract modifications and bid defenses
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What education and experience are required for the Reg Affairs Specialist role?
A Bachelor's or Master’s degree or equivalent formal academic/vocational qualification is required, along with previous experience comparable to 2+ years that provides the necessary knowledge, skills, and abilities.
Is this a remote position or does it require office work?
The role is based in office environmental conditions with a standard Monday-Friday work schedule.
What is the salary or compensation for this position?
This information is not specified in the job description.
What are the main responsibilities of the Reg Affairs Specialist?
Responsibilities include supporting preparation of EUCTR documentation, managing RIMS documents, coordinating client deliverables for regulatory compliance, liaising with clients on project status, and maintaining knowledge of SOPs and guidelines.
What makes a strong candidate for this role?
Candidates with a Bachelor’s or Master’s degree, 2+ years of relevant experience in regulatory affairs, knowledge of EUCTR and RIMS, and skills in project coordination and client liaison will stand out.
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Risks
Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.
Differentiation
Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.
Upsides
Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.
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