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 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 Youll Love MicroPort

You will find our team atmosphere challenging and 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 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 companys 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 (SOPs)
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 companys 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: Bachelors 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

Required Experience:

IC