Coord 3, Regulatory Affairs

Coord 3, Regulatory Affairs#26-05928 $54-$58 per hour Irvine, CA All On-site Job Description Hybrid Resumes are nmissing this :the candidate should have at least 5-7years of experience working in RA for medical devices by helping to prepare and finalize regulatory deliverables, evaluating changes for regulatory impact, and redlining and reviewing labeling to comply with US and EU medical device regulations and applicable standards.

Key Responsibilities:

• Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements.
• 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

Shift:

['Ability to manage competing priorities in a fast paced environment', 'Attention to detail', 'Good problem-solving, organizational, analytical and critical thinking skills', 'Good written and verbal communication skills and interpersonal relationship skills', 'Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)']

Start:

['Experience with Windchill PLM and Adobe Acrobat', 'Has certificate in regulatory affairs']

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."