Global Compliance Specialist
4 days ago
About the Role:
As a Global Regulatory Specialist at ExtendMyTeam, you will play a critical role in ensuring compliance with international regulations and standards for our medical devices, OTC, and general use products.
You will be responsible for developing and implementing regulatory strategies and plans, representing international regulatory interests on cross-functional project teams, and reviewing and approving labeling requirements for global markets.
Main Responsibilities:
- Manage the development and implementation of regulatory strategies and plans to support the timely introduction of new products and prepare/review international regulatory submissions.
- Represent international regulatory interests on cross-functional project teams for new and existing products.
- Review and approve labeling requirements for global markets, including translation materials and claims reviews.
- Evaluate change proposals for international regulatory impact.
- Maintain effective communication within the RA/QA group and cross-functional business partners.
- Support Regulatory and Quality Departments in maintaining ISO 13485 and MDSAP certifications.
Requirements:
- Bachelor's degree in Science, Engineering, or Pharmaceutical discipline.
- Direct experience with international regulatory affairs, including submissions and license renewals.
- A minimum of 3 years in a medical device, pharmaceutical, or similar organization.
- Ability to handle competing priorities and deadlines.
- Highly organized, meticulous, and detail-oriented.
- Able to work independently and in teams.
- Result-oriented, creative, and able to multitask.
- Excellent communication skills, both verbal and written.
- Experience working within the requirements of 21 CFR 820, ISO 13485, MDSAP, the Medical Devices Directive (93/42/EEC), and European Medical Device Regulation 2017/745.
What You Will Get:
- A competitive salary of $120,000 - $150,000 per year, depending on experience.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
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