I have recently partnered with an established Medical Device company who is looking to expand their team with a Reg Specialist II - Senior level team member.
This will be a 6mon contract-to-hire, onsite role.
Job Details:
The Regulatory Affairs Specialist II OR Senior RA Specialist, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements.
• Coordinate, compile, and submit Regulatory documents to competent authorities, notified bodies, Regulatory Agencies, and international business partners. Includes the preparation of key market international documents, including Technical Files.
• Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of products marketed outside the United States.
• Create detailed international regulatory plans in concert with regional Regulatory contacts.
• Evaluate proposed product modifications for international Regulatory impact, completing Regulatory Assessments as needed.
• Ensure compliance with applicable international regulations and standards
• Assist with responses to health authority questions and other Regulatory correspondence.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
• Update and maintain product eligibility to ensure right product/right country.
• Requires use and application of Regulatory concepts, practices and techniques.
• Provide solutions to extremely complex problems.
• Provide regulatory guidance to project teams, as applicable.
• Participate in the review and approval of international product labeling.
• Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.
Qualifications
• A Bachelor’s degree is required, preferably in a science or technical discipline.
• 3-5 years of direct Regulatory product registration experience required. International registration is preferred.
• Familiarity with Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299)
• Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is preferred.
• Familiarity in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking; EU MDR familiarity is preferred.
• Experience in the application of Quality Management System Standard ISO 13485.
• Experience with change assessments for internationally marketed medical devices is preferred.
• Demonstrable track of successfully managing multiple projects simultaneously is required.
• Previous experience working with globally dispersed affiliates and stakeholders is preferred.
• Excellent English written and oral communication skills are required.
• Good analytical thinking, problem solving, and investigative skills are required.
• Ability to lead others.
• Proficiency in Microsoft Office and all related applications is required.
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