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POST DATE 11/16/2019
END DATE 11/19/2019
JOB DESCRIPTIONA Regulatory Affairs job in Richardson, Texas is currently available through Belcan with one of our Medical Manufacturing clients. You will be responsible for product and working compliance related to Class-2 medical device and accessory design, manufacture and sales, obtaining regulatory approvals, and establishing and maintaining quality and environmental management systems. To be considered for this role, you will need a Bachelor's Degree in a technical discipline and 2-5 years of medical device Regulatory Affairs experience. This is a great direct opportunity with a growing company.
Regulatory Affairs Job duties:
* Partake in product development activities, including evaluating and advising personnel on regulatory impact through product life-cycle stages, ensuring that regulatory standards are understood, that a design control system is in place, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.
* Participate in the transfer of approved product design to Manufacturing to meet market introduction and other key milestone target dates, ensuring that a Device Master Record is in place (specifications, bill of materials, drawings, material specifications, labeling, etc.).
* Take part in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
* Contribute in change control activities, design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
* Assist in obtaining regulatory registrations, product clearances/ approvals, certifications and while maintaining documentation needed to support ISO, FDA, and other regulatory compliance
* Backing key business relationships by providing regulatory expertise specific to contract manufacturing, private label arrangements, due diligence for possible acquisitions, etc.
* Assist in compiling, submitting, and monitoring reports and responses to regulatory authorities.
* Support regulatory agency inspections and audits.
* Participate in the Internal Audit Program as an internal auditor.
* Support the Supplier Audit Program as an auditor.
* Support the Corrective and Preventive Action (CAPA) Program.
* Support post market surveillance (PMS) activities, including customer complaint handling and regulatory analysis efforts to determine reportability.
* Bachelor's Degree in a technical discipline required.
* 2-5 years of medical device Regulatory Affairs experience required and 1 year of QMS internal auditing experience required.
* Intermediate knowledge of/ proficiency in Microsoft Office required.
* ISO 13485 (current edition) Lead Auditor Certification and/or ASQ CQA, and/or ASQ CBA preferred.
* Intermediate knowledge of ISO 13485 preferred.
* Intermediate knowledge of ISO 14971 preferred.
* A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.
If you are interested in this Regulatory Affairs job in Richardson, TX, please apply via the 'apply now' link provided. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the engineering, IT, and professional fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website at http://www.belcan.com.