JPN_ãRAãSenior Specialist, Regulatory Affairs
JPN_ãRAãSenior Specialist, Regulatory Affairs
Posted on :
08-09-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job title: Senior Specialist Regulatory Affairs
Ensures rapid and timely approvals for respective product lines by plans on all product registration manage all product registrations preparation and documentation. Interacts with regulatory agency personnel to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registration and new regulations from government body.
- Provides input on regulatory related issues associated with compliance and achieving the business plan.
- Prioritize and plan on product registration for his/her respective product.
- Preparing coordinating and submitting regulatory applications to the local health authority.
- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
- Provide the management team with regular updates on product registration.
- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings discussions training and education.
- Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
- Supports tender operations by timely supply of accurate regulatory.
- Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
- Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
- Serves as regulatory consultant to marketing team and government regulatory agencies.
- Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.
- RARegulatory Affairs
- III
- Proactive
- PMDA
- Agility
Want
Boston Scienftific
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
