Sr. Regulatory Affairs Specialist

16 Oct, 2020

Jobs

Sr. Regulatory Affairs Specialist

MicroPort Orthopedics
Arlington, TN

Description

Overall Purpose

As Senior Regulatory Affairs Specialist, you will prepare global regulatory submissions and communicate regulatory strategies to product development teams. You will also be responsible for development, maintenance, and review of submissions, documentation, labeling, and procedures.

Skills Requirements

  • Proven leadership skills
  • Ability to work with minimal to no guidance from management to perform job function
  • 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
  • Ability to respond to inquiries and complaints from customers and regulatory agencies
  • Ability to effectively present information to other employees, management, and regulatory agencies
  • 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

Principal Responsibilities

  • Prepare and provide guidance for other employees related to the required documentation and testing for global regulatory submissions and registrations
  • Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements
  • Coordination with cross-functional teams on medical education and training events
  • Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes and custom’s requests to ensure compliance with FDA and international government regulations
  • Work with consultants to manage all submissions for a particular country or countries
  • Maintain compliance of distribution control database
  • Maintain the company’s medical device listing and device & tissue establishment registrations
  • Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
  • Represent the company with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities
  • Write and revise department standard operating procedures (SOP’s)
  • Participate in new-hire employee selection process
  • Mentor new hires as requested by management
  • Review and approve surgeon evaluation and prototype devices
  • Perform other tasks as assigned by management (e.g. due diligence, deviations, contracts, budgets, etc.)
  • Project management

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.

Accountability

  • Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations
  • Responsible for ensuring all data and information supplied is both truthful and accurate
  • Responsible for timely filing of domestic and international submissions based on product launch timelines

Experience Requirements

  • Minimum 3 years of experience in the regulatory field or regulated industry
  • Experience with medical devices, orthopedics preferred
  • Extensive knowledge of FDA and applicable international regulations and standards required

Education Requirements

  • Bachelor’s degree; B.S. preferred in engineering, life sciences, or equivalent technical field


For internal reference, this position is a job level 6.

**All candidates: Please completely fill out the online application and attach a resume that includes your current role, experience, education and contact information.**

Remote work will be considered for candidates not located in the Memphis area.

 

Search Firm Representatives Please Read Carefully: MicroPort Orthopedics. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MicroPort via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MicroPort. No fee will be paid in the event the candidate is hired by MicroPort as a result of the referral or through other means.


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Learn more here

Job posted: 2020-10-16