Regulatory Affairs Specialist II

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At MicroPort, we relentlessly strive to master every detail of our medical solutions with the purpose of prolonging and reshaping the lives of patients everywhere. We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs. In order to accomplish this, we hold true to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration. Come and join Team MicroPort!

Why You'll Love MicroPort

You will find our team atmosphere challenging and rewarding. In addition to working with a world-class team, receiving a competitive base salary and bonus opportunities, our U.S. employees also enjoy the following benefits: Medical, Dental, Vision, Maternity Leave, Life Insurance, Short-Term Disability, Long-Term Disability, Bereavement, 401(k) (up to 4% match with vesting from day 1), PTO (Starting at 18 days each year), Paid Holidays (10 each year), Employee Assistance Program, Education Assistance...and more! At MicroPort, we care about our employees and encourage them to make healthy lifestyle choices and embrace wellness opportunities to maintain their very best health and wellbeing.

*Hybrid Working Schedule Available*

Overall Summary

As Regulatory Affairs Specialist II, you will be responsible for preparing US and International regulatory submissions. You will be responsible for development, maintenance, and review of submissions, documentation, labeling, and procedures.

Your duties will include:

1. Maintain the company's medical device listing and device establishment registrations
2. Prepare domestic and international regulatory submissions, additional information request responses, and renewals
3. Review and approve labeling, promotional materials, and publications to ensure compliance with FDA and international requirements.
4. Create and maintain package inserts.
5. Maintain compliance of distribution control database
6. Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
7. Write and revise department standard operating procedures (SOP's)
8. Review and approve engineering change requests for design, manufacturing, and labeling changes to ensure compliance with FDA and international government regulations
9. Work with consultants to manage all submissions for a particular country or countries
10. Assist senior regulatory staff with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities.
11. Participate in project teams to develop regulatory strategies, testing requirements, and other documentation to ensure that regulatory submissions meet the company's product launch timelines in all identified markets.
12. Participate in new-hire employee selection process
13. Mentor new hires as requested by management
14. Review and approve surgeon evaluation and prototype devices
15. Perform other administrative tasks, as necessary (e.g. filing, spreadsheet management, etc.)
16. Perform other tasks as assigned by management (e.g. due diligence, etc.)

Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

About You

We might be a great match if you are/have:

• Basic knowledge of FDA and applicable international regulations, preferred
• Ability to work independently and/or with guidance from management to perform job functions
• Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents
• Ability to write detailed technical regulatory submissions, reports, and business correspondence
• Experience preferred with software used in medical devices including understanding of software lifecycle documentation, risk management, and regulatory requirements.
• Ability to effectively present information to other employees, management, and regulatory agencies
• Documented evidence of proficient written and verbal communication skills
• Excellent interpersonal skills
• Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities
• Computer skills, including Microsoft Office Suite and Microsoft Outlook
• Ability to work well in a cross-functional setting
• Fluency in a foreign language desirable

YOUR EDUCATION

Required: Bachelor's Degree, B.S. preferred in engineering, life sciences, or equivalent technical field.

YOUR EXPERIENCE

Minimum of 2 years of experience in the regulatory field in a regulated industry