Job description

Position: Regulatory Affairs Associate

Location: Seattle, WA

Specialty: Biotech

Schedule: M-F 8:00am-5:00pm

Pay Range: $75,000-85,000

Responsibilities:

• Lead Regulatory Affairs in project teams throughout product life cycle.
• Write/review protocols for analytical studies.
• Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.
• Support international registrations, create and maintain technical files, and prepare product dossiers.
• Prepare and maintain Design History Files.
• Lead Risk Management effort.
• Prepare and review labeling and marketing materials to ensure regulatory compliance.
• Help set the regulatory strategy for new product development.
• Keep abreast with the latest regulatory requirements and trends.
• Communicate with the FDA and other regulatory bodies concerning product submissions.

Work environment information

Position responsibilities include work in a Biosafety Level 2 lab (BSL-2) and a humidity-controlled environment.

Qualifications:

• BS/MS in life sciences, and at least 5 years of experience in an FDA-regulated medical device manufacturing company or a Ph.D. with 2 years of experience.
• Certification in regulatory affairs (preferred).
• Knowledge of US and international IVD regulations.
• Attention to detail.
• Technical system skills (i.e, spreadsheets, databases, etc)
• Ability to manage multiple projects and deadlines.
• Statistical analysis understanding and experience.
• Strong written and verbal communication skills.
• Identify compliance risks and escalate.
• Prior experience manufacturing or validating ELISA, lateral flow, and/or real-time PCR assays would be helpful.

Who We Are:

NuWest Healthcare places healthcare professionals in some of the most competitive markets in the world. Think of us as your personal networker–we find the best positions for your experience, skills, and preferred work environment at thriving companies across the country. You can fill out hundreds of applications online OR our industry-specialized team can put your resume in front of the right hiring managers foryou. We’re a top vender with our clients, meaning when we recommend a candidate, they go to the top of the pile.

What you can expect from US:

Responsiveness: Noone likes to get ghosted. You’ll get updates every step of the way

Transparency: Open and honest communication –no surprises

Career expertise: We coach you based on your specific strengths and goals to get you where you want to go

#IND-CORE

95878

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 5x8
• 8 hour shift
• Monday to Friday

COVID-19 considerations:
COVID vaccination policy: required

Ability to commute/relocate:

• Seattle, WA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: One location

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