Indiana, Other South Indiana
Our client, a medical device manufacturer in the Batesville, IN area has an immediate need for a Regulatory Engineer to join their team for a 6+ month contract.
Work with NPD Teams and Sustaining to realize compliant products based on national and international codes and standards. This position also has the responsibility for design change surveillance and general technical file maintenance for the life of the products.
This individual is responsible for quality and regulatory initiatives and strategy with internal stakeholders in support of Class I and Class 2 Product registrations in the US and Canada markets and coordinating with regional experts for International market requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned:
Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.
Define compliance strategies to certify and list products.
Provide technical review of product to ensure alignment with national and international codes.
Help maintain and sustain the product technical files for the production life of the products.
Assist product development teams in applying and understanding design standards and codes.
Submit required compliance reports to safety agencies and review 3rd party technical files and documentation.
Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.
Document work as required in a regulated industry.
Perform work in the codes and standards capacity at a Medical Device manufacturer, or hospital electrical and medical gas supplier.
Demonstrated ability to assess the application of Codes & Standards to new product designs in order to obtain & maintain the agency certifications specified by the design requirements (e.G. UL, lEC, VDE, GSA).
Knowledge of lEC based safety standards, preferred: IEC/EN/UL 60601-1, and EN 60601-2-52 Maintain necessary technical and certification files for agency review and approval, as needed.
Understand Quality System and regulatory requirements and adhere to Hill-Rom procedures and instructions.
Work with internal and external business partners to assist in registering products in the U.S., Canada and other International markets.
Work with internal team to help drive continuous improvements in relevant strategy and processes
Review engineering changes to determine codes and standards requirements.
Provide documentation for international registrations.
Provide assistance to the regulatory department as necessary, including registrations in the US and Canada.
REQUIRED QUALIFICATIONS AND SKILLS:
Excellent written and oral communication skills.
BS Degree in Engineering or equivalent experience and education.
Preferred: Experience in compliance engineering or equivalent
Preferred: Previous work with Notified Bodies
Preferred experience in the medical device industry.
Preferred: Experience with registrations for Health Canada.
Self-motivated with high performance standards.