Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

Come join our GROWING team!

Regulatory Specialist
Knowledge and experience with ISO 13485/ FDA QSR Regulations

Your tasks

Domestic and International Submission Activities

  • Assists in the completion and assembly of regulatory submissions (both international and domestic).
  • Manage and maintain regulatory files including submissions, 510K, technical files, Design Dossiers, etc.
  • Provide support to cross-functional team to define the regulatory strategy for individual products within the product development process.

 

Ensures Compliance to the Complaint Activities

  • Interfaces with customers and engineering on customer complaints and complaint investigations.
  • Ensures customer complaints, MDR’s and global vigilance reporting are addressed in a timely manner according to the risk level per company and regulatory standards.
  • Identify and initiate actions to address any customer complaints in a timely manner.
  • Assists the quality team in improving the customer complaint process and procedures.

 

Compliance Activities

  • Management of domestic and international Standards, directives, regulations, etc. for gap analysis according to the latest revisions.
  • Assist in the internal & external audits.
  • Assists in regulatory body (including Notified Body and FDA) product recalls, Advisory Notices, Vigilance, and MDR reportability.
  • Identify and initiate action to address any adverse trends or regulatory compliance issues/changes in a timely manner.
  • Work collaboratively with clients, Production Managers, and other engineers for new and sustaining product

Our expectations

  • Bachelor degree is required in the Biology, Chemistry, Chemical, Mechanical or related engineering field. Experience within the medical, or closely related industry required.
  • 2+ years of experience working as an engineer in a manufacturing environment in the medical device industry along with validation reporting and basic statistical analysis.
  • Experience in Medical Device New Product Introduction processes with strong technical writing skills.
  • Good knowledge of ISO 13485 and FDA QSR regulations.
  • Good knowledge of the MDD 93/42 and amendment 2007/47/EC, IVDD Directive 98/79/EC & the AIMDD 00/385/EEC, FDA Food and Drug Cosmetics Act.
  • Ability to work with engineering staff members, within and outside the unit, in an effective and positive manner
  • Must demonstrate ability to work independently and with others in a fast-paced, results oriented environment
  • Attention to detail and able to work independently and on a team with little supervision
  • Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers

 

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.

Freudenberg Medical manufactures minimally invasive, handheld and catheter-based devices out of our 93,000 square foot state-of-the-art facility, strategically and centrally located in Jeffersonville, Indiana. Freudenberg Medical’s culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.

Freudenberg Medical is a local, innovative, high growth company with a collaborative, high performance work environment. We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products we develop and manufacture are typically market disruptive and displace higher cost procedures.

Location: Facility in Jeffersonville, IN

We are currently hiring for a Regulatory Specialist who:

  • Is driven and focused on ensuring regulatory compliance for market-released products to ISO 13485/FDA & EU standards.
  • Is detail oriented in documentation necessary for regulatory submissions
  • Must be a self-starter who is willing to learn and take direction, and work well in cross functional teams.

Location: Jeffersonville, IN

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, dental and vision insurance, as well as 401K Match.

Do you have any questions?

Freudenberg Medical Minimally Invasive Solutions
Rachel Peterson ∙ Human Resources ∙ 2301 Centennial Blvd. ∙ 47130 Jeffersonville, IN ∙ www.freudenbergmedical.com/MIS
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