RA Admin II

CONMED Corporation; Saint-Priest; Sur place; EUR 30 000 - 45 000; Plein temps

Résumé du poste

A medical device company in Saint-Priest seeks an Admin I in Regulatory Affairs to assist in compiling and submitting necessary documentation for regulatory registrations. The role involves maintaining databases, assembling technical files, and aiding specialists in strategy forms. Candidates should have 1-3 years in regulatory affairs, with knowledge of submission processes preferred. This position requires the ability to work 8 hours a day and may handle additional tasks as needed.

Qualifications

• Minimum of 1-3 years of experience in regulatory affairs or related field.
• Ability to sit/stand for 8 hours.
• Clinical research and writing experience preferred.

Responsabilités

• Assemble information for domestic and international submissions.
• Be familiar with product registration requirements.
• Maintain Regulatory database.

Connaissances

Regulatory submission knowledge

Technical writing

Research skills

Description du poste

The Admin I Regulatory Affairs assists the Regulatory Specialists to compile and submit necessary information for domestic and international registration of products marketed by CONMED. Assists with other regulatory documentation as required by FDA and individual countries.

Key Duties and Responsibilities

• Assemble information required for domestic and international submissions.
• Be familiar with product registration requirements in international markets.
• Assist the Specialists in assembly and update of Technical Files and Dossiers.
• Initiate Regulatory Strategy forms and Notes to File as required for new and modified products.
• Maintain Regulatory database.
• Compile information for Medical Device Listings and Certificates to Foreign Government.
• Research and compile information required for customs and sales force requests.

In addition to the main responsibilities listed above the manager is allowed to USE discretion TO add further duties and tasks based on the business needs which are not explicitly listed here.

Job Requirements

Minimum Requirements

Education: N/A

Experience: Minimum 1-3 years of related experience.

Other Attributes: N/A

Physical Requirements - Ability to sit/stand for 8 hours

Preferred Requirements

Education: N/A

Experience: N/A

Other Attributes: Clinical research and writing experience preferred

Physical Requirements: N/A

ADA Disclosure

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.