Regulatory Affairs Specialist II

MicroPort Orthopedics•Lakeland, TN

1d•Hybrid

About The Position

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.

Requirements

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
Required: Bachelor’s Degree, B.S. preferred in engineering, life sciences, or equivalent technical field.
Minimum of 2 years of experience in the regulatory field in a regulated industry

Nice To Haves

Fluency in a foreign language desirable

Responsibilities

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