Regulatory Affairs Specialist I

Employment Type

: Full-Time

Industry

: Miscellaneous



Your tasks

  • Coordinates, assembles, and completes regulatory submissions (both international and domestic) for obtaining device marketing authorizations.
  • Maintains regulatory files including submissions, EU technical documentation, etc.
  • Management of domestic and international Standards, directives, regulations, etc. for gap/impact analysis according to the latest revision. This includes implementation of procedural and/or documentation updates when necessary.
  • Assists in regulatory body (including EU Notified Body and FDA), internal, & customer audits, product recalls, Vigilance, adverse event reporting, as necessary.
  • Performs in-depth review of regulatory data/information and provide oversight of query resolution and data to Supervisor.
  • Independently handle problems that arise within area of responsibility.
  • Our expectations

  • Bachelor of Science Degree in related field e.g. Microbiology, Biology or other sciences
  • Must have a minimum of 0-3 years of experience in a regulated industry (e.g., medical devices, pharmaceuticals, etc.). Regulatory Affairs experience is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Preferred to have knowledge of standards/regulations for MDSAP Countries (US, Canada, Australia, Brazil, Japan) and the EU
  • Proficiency in Microsoft Office applications (MS Word, Excel and PowerPoint).
  • Strong technical writing skills and a focus on being detail oriented.
  • Ability to communicate key ideas verbally and in writing clearly and concisely to include presentations to management and to cross-functional team members.
  • Assertive, takes initiative, self-starter, energetic, motivated and self-managed.
  • Positive, respectful, and professional attitude.
  • Able to handle diverse activities simultaneously.
  • Works well in a team-oriented, cross-functional environment.
  • Ability to handle multiple tasks and operate in a fast-paced manufacturing environment.
  • Good reasoning abilities and sound judgment.
  • Detail orientated, organizational skills and the ability to handle multiple projects.
  • Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
  • Freudenberg Medical, part of the Freudenberg Group, is a global partner for the design, development and manufacture of innovative medical devices and components. With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of manufacturing capabilities from high precision molding and extrusion to drug coatings, finished devices, and subassemblies for catheters and minimally invasive devices.

    For over 30 years, medical device and healthcare companies have trust Freudenberg Medical to manufacture their custom components and devices. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Design and manufacturing operations are located in the United States (California, Indiana, Massachusetts, Minnesota), Germany, Ireland, Costa Rica, and China.

    InHealth Technologies- In 1978, Drs. Blom and Singer pioneered the methods of tracheoesophageal voice restoration and valved silicone voice prostheses that for over the past 35 years have become the international standard for voice restoration, allowing thousands patients worldwide to regain their ability to speak. As a leading supplier of advanced voice restorations systems, our goal at InHealth is to help laryngectomies regain and preserve a vital part of their lives – their voice. InHealth is part of Freudenberg Medical.

    We are currently hiring for a Regulatory Affairs Specialist who:

  • Driven and focused to assists with domestic and international regulatory submissions, product registrations, and maintenance of regulatory files.
  • Is detail oriented working with a team to ensure that the company is aware of, and compliant to, the most current domestic and international medical device regulations, standards, and directives.
  • Self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.

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