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Regulatory Affairs Specialist II

Employer
Wright Medical Group
Location
Minnesota
Salary
Competitive

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Industry
Government and Public Services
Role
Other
Job Type
Long-Term
Hours
Full Time
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Job Description:

Work Hours

Monday to Friday

830am - 530pm with overtime flexibility as needed


The Regulatory Affairs Specialist II will draft, assemble, and support the filing of documentation and submission materials for new or existing products to regulatory authorities. Under supervision, will assure that all submissions are accurate, of high quality and well supported by literature and regulatory requirements, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines. Will also support reviewing product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and reviewing product labeling.


Essential Job Functions:

  • Assist in the preparation of regulatory submissions based on product timelines
  • Review/approve labeling, promotional materials, and publications for compliance
  • Support senior regulatory staff with strategies, submissions, and interactions with regulatory authorities
  • Maintain compliance of distribution databases
  • Participate on regulatory submission project teams
  • Works with submission project teams to ensure timely submissions
  • Assists with import/export requests, customer service needs, and other requests from internal customers.
  • Works with management to ensure submissions comply with appropriate regulations, and that data is truthful and accurate.
  • Write and revise departmental SOPs and regulatory intelligence
  • Recognizes and communicates problems that may affect timelines or regulatory objectives.


    • Skills:

  • Excellent interpersonal skills
  • Computer skills, including Microsoft Office Suite and Microsoft Outlook
  • Basic knowledge of FDA and applicable international regulations, preferred
  • Ability to work with guidance from management to perform job function
  • Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents
  • Ability to effectively present information to other employees, management, and regulatory agencies
  • Documented evidence of proficient technical written and verbal communication skills

    • Education and Experience Requirements:

  • Bachelor's degree in engineering, life sciences, or equivalent technical field preferred
  • 2+ years of Regulatory experience;
  • 3-5 years medical device industry experience
  • Experience with medical devices, orthopedics, preferred


    • Compliance:
    Every employee is responsible for adhering to the AdvaMed Code of Ethics on Interactions with Health Care Professionals and any related ethical, compliant business practices, including, but not limited to, compliance with the Company's Compliance Program, FDA regulations and guidance, Anti-Kickback Statute, and other Federal, state and/or local laws. Every employee is responsible to complete required compliance training successfully and on-time.
    This job description in no way states or implies that these are the only duties to be performed by the employee in this position. Employee will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

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