Careers that make a difference! Freudenberg Medical designs and manufactures medical devices and components for clients worldwide.  We are focused on innovative processing technologies, lean manufacturing, waste reduction, and high quality product solutions for our Fortune 100 medical device customers.  Join our fast growing team with 11 manufacturing operations around the world. 

 

Ready to make a difference?

 

The Senior Regulatory Affairs Specialist will lead the team in preparing global regulatory documents and submissions, according to Freudenberg Medical standards, for all Freudenberg Medical InHealth Technology (IHT) products.  This key team member will play a crucial role in ensuring that IHT products are available to patients in need, and they will play a significant role in the growth of the company.  If you are a detailed-oriented Regulatory professional who is passionate about making a difference in patients’ lives every day, were interested in hearing from you.  Will require the ability and willingness to travel to Carpinteria, CA.

Senior Regulatory Affairs Specialist – ENT Class I & II Devices
Costa Rica: Local Candidates ONLY - Strong English Skills

Your tasks

  • Regulatory lead on project core teams (new product development, manufacturing, obsolescence, new suppliers, etc.) providing regulatory input on all matters
  • Provide regulatory support for currently marketed products including reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory bodies (FDA, Health Canada, Notified Bodies, and ROW countries) and secure approvals
  • Communicate with regulatory agencies regarding clarification of and follow-up of submissions under review
  • Reviews marketing and sales materials for compliance to regulations
  • Reviews technical reports for incorporation into regulatory submissions
  • Maintains company registration and device listings for global regulatory agencies
  • Regulatory liaison/representative in internal and external audits
  • Prepares and maintains technical files as necessary to obtain and sustain product approvals
  • Apply technical or regulatory principles, theories and concepts.
  • Keep current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas
  • Provide mentoring and support to other members of the department
  • Prepares and maintains technical files as necessary to obtain and sustain product approvals

Our expectations

  • Bachelor's Degree and a minimum of 3 years of experience in regulatory affairs in the medical device industry
  • Experience preparing & defending regulatory submissions to the FDA (510(k), Qsubs, IDE’s, etc. are particularly preferred)
  • Willingness and ability to travel to Carpinteria, CA 
  • Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team
  • Outstanding written and verbal communication skills 
  • English proficiency at 85% working with teams in USA
  • Keen ability to prioritize work and execute in an environment of competing priorities
  • Strong organizational skills
  • Strong technical/computer skills
  • Able to review and analyze data and documentation.
  • Good reasoning abilities and sound judgment
  • Accurate and attentive to detail.
  • Ability to lead and support others.
  • Ability to read and interpret documents.

 

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.

 

SUBMIT RESUME IN ENGLISH

It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical insurance. #LI-FM2020

Learn more about the InHealth Technologies products for the ENT marketplace at http://www.inhealth.com 

Do you have any questions?

Freudenberg Medical Minimally Invasive Solutions - Costa Rica
Rachel Peterson ∙ Human Resources ∙ B. 13.4 Coyol Free Zone ∙ Alajuela, Costa Rica
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