Sr. Regulatory Affairs Specialist - Latin America
A molecular diagnostics company in Sunnyvale, CA is seeking a Senior Regulatory Affairs Specialist to join their team to assist with regulatory compliance in Latin America.
The Regulatory Affairs Specialist II will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on Latin America. Assist with ROW submissions as required. Participate in international regulatory intelligence groups and represent Regulatory Affairs on the product life-cycle management teams as needed.
ESSENTIAL JOB RESPONSIBILITIES:
- Responsible for regulatory project time lines and management of global regulatory submissions
- Provides scientific expertise and knowledge of assay development process, facilitating timely and efficient development of varied regulatory documents.
- Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines.
- Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
- Interact with global regulatory leaders and peers to expedite approval of pending registrations
- Support internal and external departments to generate protocols and reports for registration purposes
- Act as the internal subject matter expert for providing scientific and technical assistance in response to queries/comments from regulatory authorities to expedite approval of pending registrations.
- Maintain a "focused urgency" as required by specific events
- Recognize potential problems by actively reviewing and analyzing internal and external factors
- Assess potential impact and/or applicability to other related areas
- Provide regulatory training to cross-functional groups
Bachelor s degree in Life Science or related field with 3+ years of related work experience OR Master’s degree in field with 1+ years of related work experience
Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a dynamic environment
Able to confidently deal with ambiguous issues and provide input towards suitable actions
Must be detailed oriented with well-developed organizational and analytical skills
Highly proficient in Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Strong oral and written communication and presentation skills
Effective communicator of technical & non-technical information
Ability to work in a self-directed manner to see issues through to completion
Experience in Regulatory/Quality/Compliance or related departments within an IVD or medical device industry is highly preferred
Experience interfacing with Latin American Health Authorities
High preference to Spanish Language skills
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.