Medical Device Regulatory Affairs Development Analyst

Are you interested in making a difference in the healthcare industry? Do you have a passion for regulatory affairs and medical device development? Look no further, as Abbott is seeking a highly motivated and skilled Medical Device Regulatory Affairs Development Analyst to join our team. In this role, you will play a critical role in ensuring the compliance and success of our medical devices. We are looking for someone with a strong background in regulatory affairs and a keen attention to detail to help us navigate the complex landscape of medical device regulations. If you are ready to take on this exciting challenge and contribute to improving patient lives, we encourage you to apply.

Responsibilities:

1. Conduct research and stay updated on regulations and guidelines related to medical device development and approval processes.
2. Interpret and analyze regulatory requirements and communicate findings to relevant teams.
3. Collaborate with cross-functional teams to ensure compliance with regulations and guidelines throughout the entire medical device development process.
4. Prepare and submit regulatory filings, including 510(k) submissions, to obtain necessary approvals for medical devices.
5. Review and provide feedback on product labeling, promotional materials, and other documentation to ensure compliance with regulations.
6. Monitor and track changes in regulations and guidelines and recommend actions to maintain compliance.
7. Participate in regulatory audits and inspections, as needed.
8. Develop and maintain relationships with regulatory authorities to ensure a smooth and efficient approval process for medical devices.
9. Serve as a subject matter expert on regulatory affairs and provide guidance to internal teams.
10. Continuously evaluate and improve internal processes to ensure efficiency and compliance with regulations.
11. Keep accurate records and documentation of all regulatory activities.
12. Collaborate with the Quality Assurance team to ensure adherence to quality standards and regulations.
13. Mentor and train junior team members on regulatory affairs processes and procedures.
14. Contribute to the development and implementation of company policies and procedures related to regulatory affairs.
15. Represent the company in industry meetings and conferences to stay updated on regulatory trends and best practices.

According to JobzMall, the average salary range for a Medical Device Regulatory Affairs Development Analyst in Alameda, CA, USA is $71,000 to $100,000 per year. This can vary depending on factors such as experience, qualifications, and the specific company or organization the analyst is employed by.

From removing the regular pain of finger sticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s blood donations to ensure a healthy supply, our purpose is to make the world a better place by bringing life-changing health technologies to the people who need them. That’s our commitment to helping you live your best life.