Nerac, Inc Hiring for Regulatory Analyst/Medical Writer Job at Remote Full Time

Regulatory Analyst/Writer (Medical

Device)

Industry Medical Devices

Discipline Regulatory Affairs

Location Remote – Home Office

Reports To Senior Analyst/Medical Writer

Nerac Analysts:
The Nerac Life Sciences/Medical Device Team works with medical device companies worldwide to support their regulatory approval/recertification and monitors the on-going safety and efficacy of their marketed products. The Regulatory Analyst/Writer will be responsible for providing regulatory support during and after product regulatory approval.

Key Responsibilities:

• Perform literature research and provide analysis

• Review device documentation and draft reports

• Communicate with clients in a professional manner

• Actively pursue continual learning and job-related development

Required Education/Experience/Characteristics:

• Undergraduate or advanced degree in biomedical or health sciences

• Demonstrated scientific or clinical writing skills

• Ability to review data and provide analysis in a clear and concise manner

• Advanced searching skills (Embase, PubMed, etc.)

• Experience reading, writing, and/or analyzing clinical or scientific literature

• Proven ability to multitask and adhere to timelines

• Proven ability to work in a dynamic team environment

• Excellent Microsoft Office skills (Word, Excel, Outlook)

Preferred Skills and Knowledge:

• Experience creating Clinical Evaluation or Literature Reports for Medical Device submissions (US,

EU, China, Japan, Canada)

• Knowledge of medical device regulations and guidance

• Strong analytical skills, both qualitative and quantitative

• Good client service skills

• Medical writing experience

• Deep intellectual curiosity about industry trends and emerging technologies

• Creativity/originality in finding the right solutions for clients

• Entrepreneurial, enthusiastic, collegial, and collaborative approach to work

• Exceptional organizational skills plus keen attention to detail

• Ability to work with globally located team members

A writing sample will be required upon request.

For more information please go to: https://www.nerac.com/career-opportunities/’
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Work Location:

• Fully Remote

Job Types: Full-time, Part-time

Pay: $40.00 – $60.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

COVID-19 considerations:
Nerac has long supported a virtual workforce and is well equipped to conduct all business and essential work functions via remote home office.

Education:

• Master’s (Required)

Experience:

• Medical Writing: 1 year (Preferred)
• Regulatory reporting MDD/MDR CER: 1 year (Required)

Work Location: Remote