10 дней назад
Analyst Reg Aff
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst Reg Aff (Medical Devices): Executing regulatory submission processes and preparing product approval packages for medical devices with an accent on compliance, regulatory strategy, and timely approvals. Focus on resolving moderately complex regulatory issues, supporting cross-functional projects, and maintaining legal market status.
Location: Mexico City, Mexico
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions focused on preventing, treating, and curing complex diseases.
What you will do
- Execute the submission process for product approval documents in line with filing requirements.
- Develop plans for submitting medical device approval documents and maintaining the approved status of marketed devices.
- Compile product approval packages and address issues that could delay approval.
- Provide regulatory support and expertise for moderately complex cross-functional projects.
- Prepare regulatory strategies aligned with business objectives, R&D priorities, and applicable laws and guidance.
- Manage low-complexity projects independently and serve as a technical expert within Regulatory Affairs.
Requirements
- University or bachelor’s degree, or equivalent, in a technical-related discipline.
- 0–2 years of related experience.
- Bilingual Spanish and English proficiency required.
- Working knowledge of the regulatory environment, including compliance requirements, laws, regulations, and guidance.
- Strong organizational, project management, decision-making, prioritization, communication, and problem-solving skills.
Culture & Benefits
- Inclusive work environment that respects individual dignity, diversity, and merit.
- Work within a global healthcare organization focused on innovation across MedTech and medicine.
- Collaboration across regions, countries, R&D, business, and other functional areas.
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