Regulatory Affairs Specialist
Regulatory Affairs Specialist
24 Seven Talent
Los Angeles Metropolitan Area
See who 24 Seven Talent has hired for this role
Regulatory Affairs Specialist
-Contract length: through end of 2024
-Location: San Clemente, CA (onsite)
-Hours: fulltime, M-F (8am-5pm)
-Set pay rate: $39/hr
**Must be able to commute and work onsite Mon-Fri
Our client, a large healthcare company is seeking a Regulatory Affairs Specialist to join their team! As the Regulatory Affairs Specialist you would provide regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products.
Responsibilities:
- Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
- Plans and organizes registration packages. Prepares registration packages in line with local regulatory requirements and guidelines.
- With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams.
- Assists in the preparation of agency meeting packages and strategies for agency meetings.
- Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review.
- Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
- Work on special assignments as they arise
Qualifications:
- 3-5 years of experience in Regulatory Affairs, Research, Development or related area.
- Preferred software experience: 510(k) / Q-sub / Response experience, Medical Device Technical Documentation experience
- Able to follow scientific arguments
- Good interpersonal skills
- Good oral and written communications and negotiation skills
- Developing understanding of business needs
- Exceptional interpersonal skills; professional demeanor and attitude High level of attention to detail
- Excellent verbal and written communication skills
- Ability to prioritize key business objectives and respond quickly to changing priorities
- Ability to work independently with minimal daily instruction
- Able to multitask and work in a fast-paced environment
Education:
- Bachelor’s degree from an accredited college or university is required, Masters preferred Minimum 3 years of experience
-
Seniority level
Associate -
Employment type
Contract -
Job function
Legal, Quality Assurance, and Health Care Provider -
Industries
Health and Human Services, Public Health, and Hospitals and Health Care
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Inferred from the description for this job
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Medical insurance -
Dental insurance -
Vision insurance
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