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Regulatory Affairs Strategy Associate

Astrix

Lake Forest, Canada · पूर्णवेळ

अर्ज करणारे पहिले व्हा

अनुभव
७+ वर्षे
पगार
USD 50 – USD 58 / hour
रिक्त जागा
1
पोस्ट केले
१३ तास पूर्वी
कार्य मोड
कार्यालयात
शिक्षण
Bachelor's degree or equivalent experience
सारांश
अर्ज करणे आवश्यक आहे

तुम्ही जिथे काम कराल

नोकरीचे वर्णन

About the Role

Join a global leader in ophthalmic solutions as a Regulatory Affairs Strategy Associate dedicated to advancing innovative eye care products. This position is based onsite in Lake Forest, CA, offering an 8-month contract with the possibility of extension. The company is recognized as the largest device manufacturer worldwide, with additional segments in Surgical and Vision Care.

Key Responsibilities

  • Formulate and implement regulatory strategies for both new and established ophthalmic products.
  • Oversee submission processes, regulatory approvals, and renewal management for products.
  • Collaborate closely with manufacturing locations, regulatory bodies, and international teams to ensure adherence to regulatory requirements.
  • Support portfolios encompassing medical devices and pharmaceuticals.
  • Ensure ongoing compliance with GxP standards, Standard Operating Procedures, and quality benchmarks.

Required Qualifications and Experience

  • Bachelor's degree or equivalent professional experience.
  • More than seven years' experience in Regulatory Affairs.
  • Background in medical device and/or pharmaceutical regulatory environments.
  • Comprehensive understanding of global regulatory submission protocols and compliance.
  • Exceptional communication capabilities and meticulous attention to detail.

Benefits and Work Environment

  • Hourly pay rate between $50.00 and $58.00.
  • Healthcare benefits including Medical and Dental coverage.
  • Holiday leave, Paid Time Off, and 401(k) plan with matching.
  • Opportunity to contribute to industry-leading ophthalmic healthcare products.
  • Collaborative and innovative team culture.
  • Chance to make a significant global impact in patient health care.

Additional Information

The job description encapsulates a comprehensive list of preferred skills; however, candidates exhibiting some of the outlined qualifications are encouraged to apply. The employer welcomes discussions to better understand individual candidate strengths and potential contributions.

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