Job Description :
Pay Range $63.89hr - $68.89hr
Responsibilities :
- As a Senior Professional, a candidate will leverage candidate extensive expertise, integrating analysis, development, testing, and implementation within the candidate area of competence.
- Candidates will interpret and functionally influence policy and guidelines, developing processes and systems to deliver functional objectives.
- Planning candidate work according to agreed targets within a project-driven environment, candidates will provide functional advice and guidance to colleagues and customers.
Experience :
- With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs.
- Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files.
- Candidate expertise includes determining product classification and whether product changes require regulatory submissions, particularly for software and hardware devices.
- Candidates have a solid understanding of relevant standards such as ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1, demonstrated through coursework or submissions requiring the use of each standard.
Teamwork and Collaboration :
Candidate excellent communication and interpersonal skills enable seamless collaboration across departments and interaction with design and development teams.
Experience with Business Tools :
- Proficient in utilizing business tools such as E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro, you leverage these tools effectively in candidate role.
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