Are you a highly organized and detail-oriented regulatory professional with a passion for medical devices? Do you thrive in a fast-paced environment and enjoy collaborating with cross-functional teams? If so, we encourage you to apply for our International Medical Device Regulatory Affairs Specialist position!
TasksIn this role, you will be responsible for ensuring our medical devices receive timely approvals and maintain registration status in designated international markets. Key responsibilities include:
- Managing the entire international medical device registration process, from submission to approval.
- Maintaining up-to-date knowledge of international regulations and providing guidance to internal and external stakeholders.
- Supporting local distributors and consultants with registration activities.
- Reviewing and approving artwork and packaging labels.
- Advising cross-functional teams on regulatory compliance and proposing solutions.
- Developing and implementing change management strategies for products and processes.
- Monitoring regulatory changes and communicating updates to ensure compliance.
- Liaising with regulatory agencies to address any issues related to product registration, pre-market evaluation, and post-market surveillance.
The ideal candidate will possess the following qualifications and skills:
- Bachelor's degree in a relevant scientific or regulatory field.
- Proven experience in medical device regulatory affairs, with a focus on international submissions.
- Strong understanding of international regulatory requirements (e.g., FDA, EU MDR, etc.).
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently and as part of a team.
- Proficiency in relevant software and databases.
We offer a competitive salary and benefits package, including:
- Health insurance
- Paid time off
- Professional development opportunities
- Collaborative and supportive work environment
If you are interested in this exciting opportunity, please submit your resume and cover letter.
