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Senior regulatory affairs specialist - remote / telecommute

Irvine
Cynet systems Inc
Regulatory affairs specialist
€46,000 - €36,546 a year
Posted: 21 December
Offer description

Pay Range: $60/hr - $64/hr


Responsibilities

* Participate in assessing and collating regulatory impact and developing regulatory strategy.
* Collaborate and approve change requests/change notifications.
* Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content.
* Other incidental duties assigned by Leadership.


Additional Skills

* 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.
* 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.


Education and Experience

* Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry).
* 5-7 years of experience required.
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