Regulatory Affairs Specialist II

Employment Type

: Full-Time

Industry

: Miscellaneous



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The Regulatory Affairs Specialist II is responsible for implementation of regulatory strategies including domestic and international submissions and provide support to product project teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

  • Provide regulatory support through the product life cycle.
  • Develop regulatory strategies, establish timelines, manage change control and prepare submission related documentation.
  • Lead, prepare and successfully complete international submissions for new and modified products. 
  • Interface with international colleagues to establish requirements, prepare submissions and obtain approvals.
  • Support 510(k)s, IDEs, PMAs submissions for new and modified products.
  • Provide timely review and approval of product and manufacturing changes as well as product labeling and marketing claims for regulatory compliance.
  • Drive CE marking activities, including preparation and maintenance of product technical files and clinical evaluations.
  • Interface with colleagues and regulators as necessary to submit, respond to questions and obtain registrations, licenses and approvals.
  • Support New Product Development and Sustaining Engineering Project Teams.
  • Provide team guidance and develop supporting regulatory plans and rationale.
  • QUALIFICATIONS:

  • Must have a good knowledge of the U.S. and European medical device regulations.
  • Must have excellent written and verbal communication skills.
  • Must be organized and logical; able to prioritize and handle several projects concurrently.
  • Must have technical writing skills and be proficient at generating successful submissions for the appropriate audience.
  • Must be able to provide guidance and help mentor personnel.
  • Must be self-motivated and be able to work independently to achieve results.
  • Must be able to maintain confidentiality with company documentation and discussions.
  • EDUCATION and/or EXPERIENCE :

  • BS in a scientific discipline with 3 years minimum employment in medical device registration, compliance and/or quality systems.
  • Must have a strong verbal and written command of the English language.
  • Must be able to understand, describe and summarize laboratory and clinical data. 
  • Mathematical skills commensurate with educational background.
  • Must be able to understand, communicate and present technical information in a logical manner such that it can be understood by a layman.
  • Must also be able to anticipate and mitigate potential issues.
  • Must be able to operate computer and office equipment as needed.
  • Must be able to travel via airlines as needed.
  • LI-TECH


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