ESSENTIAL DUTIES AND RESPONSIBILITIES:

*Supports and provides regulatory expertise to assigned projects with a focus on international Telecom / radio frequency regulations and standards.

*Reviews and gap-analyses of technical and design control documentation; consideration of current standards and regulations, including Telecom/radio frequency regulatory requirements.

*Ensuring of compliance of medical and non-medical devices/solutions using telecom / radio frequency.

*Create and execute Regulatory Strategies and Plans for assigned products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labelling, software, and suppliers.

*Preparation and submission of country registration in agreement with the product road map.

*Performs quality related tasks in assigned development projects.

*Perform assigned Corrective and Preventive Actions for medical and non medical devices.

*Supporting the revision of various regulatory and quality compliance SOPs and work instructions to ensure compliance with local and international regulation.

OTHER DUTIES AND RESPONSIBILITIES:

Report:

*On request, the employee shall report about the status of a project and deviations from a stated time-line or quality and advise the supervisor of corrective measures to be taken.

*The employee will immediately report all potential risks, operational failures, time constraint problems and extraordinary events that will negatively impact the project to the supervisor

*Supervision: the employee is entitled to inform himself/herself about all matters concerning his/her project at all times. The employee is responsible for testing the quality of the products and services, which are intended for his/her respective project. The employee must decide on measures to be taken, should the quality differ from the stated specification.

Individual tasks:

*In addition to the above-mentioned tasks, the employee is obliged to perform other tasks upon request.

QUALIFICATIONS AND SKILLS NEEDED:

Education:

*Life Science, Technical or electrical engineer or equivalent.

*Bachelor Degree

Experience:

*At least 5 years of experience working with regulated products (including medical devices) using Telecom / radio functions.

*Telecom / Radio certification testing experience.

*Product and Development Life Cycle of regulated devices.

*Good trouble shooting and communication skills.

Knowledge:

*Sound knowledge of international telecom/radio regulatory requirements and certification processes (e.g. US, EU, China, Japan, Canada)

*Sound knowledge of international telecom/radio certification procedures, including details on submission, required exhibits, labeling and market surveillance mechanisms.

*21 CFR Part 820, 21 CFR Part 11 advantageous.

*Good command of English, second language preferred.

EEO Statement:

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.