Regulatory Affairs Strategy Associate
Lake Forest, Canada · Tempo pieno
Sii il primo a candidarti
- Esperienza
- 7+ anni
- Stipendio
- USD 50 – USD 58 / hour
- Aperture
- 1
- Pubblicato
- 8 ore fa
- Modalità di lavoro
- In ufficio
- Istruzione
- Bachelor's degree or equivalent experience
- Riprendere
- È necessario candidarsi
Dove lavorerai
Descrizione del lavoro
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.