ProClinical has a brilliant opportunity for an RA Associate to be based in Raynham, MA. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors.
- Activities to prepare regulatory submissions for re-registration; and the tracking of requests/responses to International Affiliates and BU Regulatory and track Approvals.
- Prepare and post documentation necessary for each country to re-register product.
- Monitor and respond to questions posed by regulatory affiliates and Business Unit regulatory associates.
- Process Certificates to Foreign Governments (CFG's) through the FDA and Certificates of Free Sale (CFS's) through the appropriate MOH (Ministry of Health)
- Process POA's and Letters of Explanation
- Maintain various tracking logs which may include project approvals
- Assist in the Maintenance tasks such as copying, scanning, filling and sending FED EX express packages.
Skills and Requirements:
- A minimum of a Bachelors degree is required.
- A minimum of 2+ years of regulated industry experience is required.
- Basic working knowledge of FDA and/or European regulatory requirements is required.
- Experience with 510k's, Technical Files, PMA's and design dossiers is preferred.
- Experience with US and EU regulatory requirements is preferred.
- International experience outside of the US and EU is an asset.
- The ability to develop and maintain excellent working relationships with regulatory personnel is required.
- Ability to write, proofread and check documents for accuracy;
- ability to relate information to requirements; and
- ability to identify inconsistencies will be needed.
- Proficiency in the use of technology including MS Office Software Packages and Internet for word processing, spreadsheet analysis, database analysis, Internet research, etc. will be required.
- Excellent communication, organizational and problem-solving skills are required.
- Must be able to work successfully within a team environment and as an individual contributor.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Estella Nchumuluh on +1 267 943 3657 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.