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اے

Regulatory Affairs Strategy Associate

Astrix

Lake Forest, Canada · مکمل وقت

درخواست دینے والے پہلے فرد بنیں۔

تجربہ
7+ سال
تنخواہ
USD 50 – USD 58 / hour
کھلنا
1
پوسٹ کیا گیا
10 گھنٹے قبل
کام کا موڈ
دفتر میں
تعلیم
Bachelor's degree or equivalent experience
دوبارہ شروع کریں۔
درخواست دینے کی ضرورت ہے۔

جہاں آپ کام کریں گے۔

ملازمت کی تفصیل

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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