Regulatory Affairs Specialist

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
How you´ll make an impact
Completes and maintains regulatory approvals and clearances of assigned products.
Create regulatory submissions/playbook, exercising judgment to protect proprietary information) for finalization and submission; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, COE, Canada)
Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activites in Edwards systems to ensure compliant product distribution.
Identify trends, assess impact, analyze alternatives and recommend action plans
Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, and resolving conflicts between those requirements and development issues, and/or reporting to management.
Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulations
Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies
Review and approve materials (e.g., collateral) from cross-functional teams
**Incidental**: Other duties as assigned by Management
What you will need
Bachelor's Degree in related field, 3 years experience previous related experience
Required in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred
**Other**: Coursework, seminars, and/or other formal government and/or trade association training
Preferred Experience in preparing domestic and international product submissions
Advanced Portuguese and Spanish
Intermediate English
Knowledge of Brazilian regulation
Knowledge of other regulations in the region
What else will help you
Good medical writing skills
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Good problem-solving, decision-making, organizational, analytical and critical thinking skills
Good written and verbal communication skills and interpersonal relationship skills
Ability to read, write and speak English required; Fluency in other language (e.g., German, French, Spanish, Italian, Portuguese, Russian, Polish) preferred
Solid knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Solid knowledge of new product development systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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