Regulatory Affairs Senior Specialist
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Position Summary
The Regulatory Affairs Senior Specialist is responsible for executing and coordinating global regulatory activities for in vitro Diagnostics (IVD) products for which the company serves as the Legal Manufacturer. The role supports product launches market expansion and lifecycle management by ensuring compliance with applicable global regulatory requirements.
Key responsibilities
- Execute regulatory activities to support product launches market expansion and maintenance of existing approvals
- Assess regulatory impact of product and labeling changes and support related change control activities
- Coordinate regulatory documentation and labeling updates required to sustain product compliance
- Support communications with regulatory authorities and Notified Bodies as needed
- Monitor regulatory and standards changes and share relevant updates internally
- Represent Regulatory Affairs in cross-functional projects
- Perform other Regulatory Affairs related activities as required
Required Qualifications
Regulatory Experience
- Experience in regulatory activities for IVD products or related medical devices
- Practical experience with regulatory requirements in at least one region (e.g. EU APAC Latin America)
- Experience interacting with regulatory authorities and/or Notified Bodies
Execution & Coordination
- Ability to independently manage regulatory activities and coordinate with internal stakeholders at a Senior Specialist level
- Experience maintaining documentation for product approvals and certifications
Communication
- Ability to collaborate effectively with regulatory authorities and internal crossfunctional teams
- Proficiency in English for regulatory documentation and professional communication
Analytical Ability
- Ability to assess regulatory impact of product or labeling changes
- Sound judgment in regulatory decisionmaking including adverse event handling
Flexibility & Learning
- Ability to adapt to regulatory changes
- Motivation to continuously develop regulatory knowledge and apply it in practice
Preferred / Advantage
- Experience in global regulatory project coordination
- Experience with international product registrations
- Experience interacting with global regulatory stakeholders
- Strong regulatory writing skills
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ID Infectious Disease
LOCATION:
Japan > Matsudo : 357 Nakahara Matsuhidai
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Senior IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
