Regulatory Affairs Specialist
hace 2 semanas
Carrying out, controlling, and implementing activities related to the company's quality system.
Carrying out, controlling, and implementing the regulatory processes applicable to the company's activities and products.
Providing support to the RAQA manager in the department's activities.
CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.
At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.
CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That’s a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.
Responsible for activities related to the Regulatory Affairs and Quality Assurance department.
- Graduated in pharmacy or another health area.
- Solid knowledge and understanding of local and global regulations relevant to medical devices.
- Advanced knowledge in Microsoft Office Suite including Word, PowerPoint, and Excel - advanced.
- Ability to understand, read, write and speak English (advanced).
- Knowledge of quality systems and good manufacturing, storage, and distribution practices for medical products.
- Availability to work in the office.
- Good problem-solving, decision-making, organizational, analytical, and critical thinking skills.
- Good written and verbal communication skills and interpersonal relationship skills.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to build productive internal/external working relationships.
- Adhere to company rules, requirements, and policies.
- High ability to read and understand legal and technical material.
- Prolonged sitting in front of a computer
- Minimal of 5 years’ experience in Regulatory Affairs and Quality Assurance, minimum of 02 years in the position.
- Occasional trips, less than 5% of the time.
- Ensures a thorough understanding and Active involvement of the products development and task assigned.
- Gathers and assembles information for submission of new registrations, variation, and renewal registrations of CooperVision products, including labeling documentation in accordance with regulations and relevant guidelines.
- Proper evaluation of technical documents, change controls, dossiers, gap assessments, etc.
- Prepare regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance when required.
- Retrieve, review and request of packaging materials and samples as necessary.
- Request and track of legal documents for regulatory submissions,
- Communication & submission of documentation, as required.
- Involvement with local competent authorities and trade associations on an as needed basis.
- Researches, collects data to respond requests from regulatory agencies or distributors to prepare and submit documentation for marketing approvals.
- Maintain of RA and QA projects in Global Data Base, including internal systems.
- Review, approve and submit marketing and commercial materials.
- Regulatory intelligence: monitoring, evaluating, and reporting on publications and changes relating to the business.
- Support quality activities according to demand: product complaints, non-conformities, environmental control, product reception, trainings, nationalization, internal and external audits.
- Assures proper decision making in case of Quality issues.
- Support of regional, and as needed global, regulatory demands to the different internal stakeholders.
- Responds to corporate inquiries and follow up to internal processes: RAID, PRCO, PCO´s
- Identify trends, assess impact, analyze alternatives, and recommend action plans.
- Management of local PO and payments
- Translation of technical documentation.
- Staying up to date - constant self-training
- Managing a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property and ensuring privacy.
- Can act as a designee for the RAQA SOLA Manager when required.
CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing pr
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