### Job Title: International Product Safety & Regulatory Specialist
**Job Summary:**
The International Product Safety & Regulatory Specialist is responsible for ensuring that the company's products comply with global safety and regulatory standards. This role involves monitoring international regulations, managing compliance processes, and coordinating with various departments to guarantee that all products meet the required safety standards before market entry.
**Key Responsibilities:**
1. **Regulatory Compliance:**
- Monitor and interpret international regulatory requirements related to product safety.
- Ensure products comply with global regulatory standards, including those of the FDA, CE, RoHS, REACH, and other relevant authorities.
- Prepare and submit regulatory documents to obtain necessary approvals and certifications.
2. **Safety Assessment:**
- Conduct safety assessments of products, including hazard identification and risk analysis.
- Develop and implement product safety testing protocols.
- Review and approve product labeling and packaging to ensure compliance with safety standards.
3. **Documentation and Reporting:**
- Maintain comprehensive records of regulatory submissions, approvals, and safety assessments.
- Prepare and present reports on regulatory compliance status to management.
- Develop and update regulatory documentation, including safety data sheets (SDS) and technical files.
4. **Cross-functional Coordination:**
- Work closely with R&D, Quality Assurance, Legal, and Marketing teams to ensure regulatory requirements are met during product development and launch.
- Provide guidance and training to internal teams on regulatory compliance and product safety matters.
- Liaise with external regulatory bodies and industry associations.
5. **Continuous Improvement:**
- Stay current with changes in international regulations and standards.
- Participate in industry forums and conferences to gain insights into regulatory trends and best practices.
- Recommend and implement process improvements to enhance regulatory compliance and product safety.
**Qualifications:**
- Bachelor's degree in a relevant field (e.g., Chemistry, Biology, Engineering, Regulatory Affairs).
- 3+ years of experience in a regulatory affairs or product safety role, preferably in a global context.
- In-depth knowledge of international regulatory standards and safety requirements.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in regulatory documentation and submission processes.
- Ability to work independently and manage multiple projects simultaneously.
**Preferred Qualifications:**
- Advanced degree in a related field.
- Regulatory Affairs Certification (RAC).
- Experience in the medical device, pharmaceutical, or consumer products industry.
- Familiarity with software tools used for regulatory compliance and documentation management.
**Work Environment:**
- This position may require occasional travel to international locations for regulatory meetings, audits, and inspections.
- Flexible work arrangements may be available, including remote work options.
**Application Process:**
Interested candidates should submit a resume and cover letter outlining their qualifications and experience related to this role. Please include examples of previous regulatory submissions and safety assessments conducted.
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