- Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management
- Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE's, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files)
- Provide guidance on regulatory requirements necessary for contingency planning
- Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process
- Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
- Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions
- Other incidental duties assigned by Leadership.
- Coursework, seminars, and/or other formal government and/or trade association training required
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
- Good written and verbal communication skills and interpersonal relationship skills
- Good problem-solving, organizational, analytical and critical thinking skills
- Solid knowledge and understanding of global regulations relevant to medical devices, 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
Specialist, Regulatory Affairs - Bardi, Italia - Edwards Lifesciences
Descrizione
For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE:
EW) has operated at the intersection of groundbreaking medical innovation and improved patient care.
Put simply, we exist because we're committed to creating a world where every patient who should be monitored will be monitored with smart technology.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability.
We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities.
Those who choose to join us will be part of a 'once-in-a-lifetime' journey to improve the quality of care and outcomes for millions of patients around the world.
Appendix:
For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99:
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 will make an impact:
What you'll need (required):
Bachelor's Degree in related field with 3 years experience in related experience
What else we look for (preferred)