Job Description

Our Large Medical Device Manufacturer Client is looking for Regulatory/Compliance Associate - Hybrid Role .

Please let me know if you are interested or anyone who might be interested.

***THIS IS NOT AN IT ROLE***

Job Details:

Client: Large Medical Device Manufacturer Client

Title: Regulatory/Compliance Associate - Hybrid Role

Duration: 6-18+ Months

Location: Denver, CO 80226

Hourly Rate: $20.00-25.00/ Hour on W2 ONLY

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Notes:

• Needs manufacturing regulatory and not clinical
• Receives Data sets and documents. Review and provide findings and summaries to respond to requests
• Electronic heavy paper management to provide and write a response to any requests
• Small regulatory team
• Needs GMP (good manufacturing practice ) experience and Not GCP(Good clinical practice)
• Experience in IND and NDAs. INDs are regulatory filings approval to get clinical trials and NDAs approved filing with FDA to market. Also experience in CMC (chemistry manufacturing and Control)

Job Posting Description

• Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
• Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
• Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
• Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
• Reviews product labeling and marketing materials for accuracy and compliance with regulations.
• Responds to customers’ and/or authorities’ requests/inquiries dealing with regulations and product compliance.
• Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
• May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.

Job Posting Qualifications

Bachelor's Degree, with minimal to no prior relevant work experience or equivalent experience (1-4 years) with document management systems or regulatory submissions.

Best regards,

Vishnu Das Natesan (Vish)

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