• Regulatory Affairs Specialist

Cutting-edge, proprietary technology has put Ellman International on the map as the leading developer, manufacturer, and direct marketer of radiowave surgical devices used in surgi-centers, physician offices an OR's throughout the world. Ellman International was recently acquired by Baird Capital Partners and is entering an exciting growth stage.

We are seeking a Regulatory Affairs Specialist largely focusing oninternational registrations.

Duties include:

• Regulatory and Quality contact for International Distributors
• Partner with international distributors for regulatory registrations and filings
• Interface with internal Internatioanl Sales Team
• Catalog and maintain international regulatory documentation.
• Responsible for maintaining technical files.
• Prepare technical documentation needed to demonstrate compliance with applicable international standards.
• Interface with Notifield Bodies and outside consultants for both internal and external quality audits.
• Responsibale for international regulatory reporting
• Involved with Corrective and Preventative Actions (CAPA's) and Customer Inquiries, Complaints and regulatory reporting
• Relentless in the pursuit of continuous improvement across the organization.
• Work with outside regulatory and QSR consultants

work Experience, Skills and Education Required

• BS / BA degree required preferably in a science related field.
• 2 years quality experience in the medical device industry
• Working knowledge ofISO, CE, FDA regulations.
• Proven track record making good business decision with a practical
• Proven track record as a great team player

Please submit resumes with cover letter to careers@ellman.com.

• Senior Mechanical Engineer-Medical Devices

Cutting-edge, proprietary technology has put Ellman International on the map as a leading developer, manufacturer, and direct marketer of radiowave surgical and OR's throughout the world.

We are seeking a Sr. Mechanical Design Engineer to be a part of our Research and Development Team working both on new capital and disposable components.   

Duties include:

• Lead design efforts of new electrosurgical handpieces and electrodes from concept to release.
• Work in small team environment on development of new electrosurgical generators from concept to releases.
• Generate CAD drawings and models of existing products.
• Analysis of manufacturing and process capability of design.
• Interfaces with and support internal manufacturing
• Interfaces with suppliers
• Involved in Risk Management activities
• Support preparation of technical documentation needed to demonstrate compliance with applicable international standard.
• Relentless in the pursuit of continuous improvement across the organization.   

  Required Work Experience, Skills and Education

• BS in mechanical engineering or related fieldrequired, MS preferred
• 5 years experience in medical device industry working with Class II or III product
• Working knowledge of SolidWorks
• Strong interpersonal skills
• Proven track record as a great team player
  

The mechanical engineer will report to the Sr. Director of R&D, Regulatory, and Clinical Affairs and will receive a competitive compensation.

Please submit resume with cover letter to careers@ellman.com