Regulatory Affairs Project Manager
1 week ago
We are seeking a highly skilled Regulatory Affairs Project Manager to oversee and coordinate regulatory activities for our medical devices. The ideal candidate will have a strong background in regulatory affairs and experience with US and international medical device regulations.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with FDA and international regulations.
- Prepare and submit documentation for global regulatory registration, including 510(k) submissions and software/instrument submissions.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product development lifecycle.
- Maintain up-to-date knowledge of international medical device regulations and quality standards.
- Interface with regulatory agencies, including the FDA, to ensure compliance and support market entry of medical devices.
- Develop and maintain regulatory procedures and processes to ensure compliance and efficiency.
Qualifications:
- Bachelor's degree in Life Sciences, Engineering, or a related field.
- Minimum 5 years of experience in Regulatory Affairs, with a focus on medical devices.
- Strong technical and medical writing skills, with the ability to communicate complex regulatory information to both technical and non-technical stakeholders.
- Excellent verbal and written communication skills, with the ability to interface with regulatory agencies and cross-functional teams.
About Tek Support:
Tek Support is a leading provider of medical devices and solutions. We are committed to delivering high-quality products and services that meet the needs of our customers. Our team is passionate about innovation and excellence, and we are seeking a Regulatory Affairs Project Manager who shares our values and commitment to quality.
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