Regulatory Affairs Specialist

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