Senior Regulatory Specialist - remote

Talentify.io; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading company in Medical Imaging and Artificial Intelligence is seeking a Regulatory Affairs professional. This remote position offers career advancement, a collaborative environment, and opportunities for continuous learning. Candidates should have a Bachelor's degree and extensive experience in regulatory submissions and FDA regulations.

Benefits

Flexible work hours

Career advancement opportunities

Collaborative and agile work environment

Continuous learning opportunities

Qualifications

• 6-8 years of experience in a regulated industry, preferably FDA and Software as a Medical Device.
• Experience drafting and submitting regulatory filings, including Q-Submission requests and 510(k) filings.

Responsibilities

• Represent Regulatory Affairs on cross-functional project teams.
• Create and maintain technical documentation for regulatory approval.
• Assist in the preparation and review of regulatory submissions.

Skills

Knowledge of FDA Quality System Regulations

Excellent written and oral communication skills

Education

Bachelor's degree in a relevant field

Job description

Employer Industry: Medical Imaging and Artificial Intelligence

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work remotely with flexibility in work hours
- Join a dynamic team with expertise in various fields
- Collaborative and agile work environment
- Continuous learning opportunities to enhance your professional skills

What to Expect (Job Responsibilities):
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input on product lifecycle planning and regulatory requirements
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance
- Create and maintain technical documentation required for obtaining and/or maintaining regulatory approval for products
- Assist in the preparation and review of regulatory submissions to authorities
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement necessary regulatory actions

What is Required (Qualifications):
- Bachelor's degree in a relevant field or equivalent experience
- Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820
- 6-8 years of experience working in a regulated industry, preferably FDA and Software as a Medical Device
- Experience drafting and submitting regulatory filings, including Q-Submission requests and 510(k) filings
- Excellent written and oral communication skills

How to Stand Out (Preferred Qualifications):
- Experience with US FDA Class I and II medical devices; additional experience with Class III devices is a plus
- Knowledge of Medical Devices Regulations (MDR 2017/745, ISO 13485, ISO 14971)
- Experience interacting with Regulatory Authorities, including Q-Submission meetings and regulatory inspections

#MedicalImaging #ArtificialIntelligence #RegulatoryAffairs #RemoteWork #CareerGrowth

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