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Senior Regulatory Affairs Specialist

3 months ago

Green Oaks, United States Abbott Full time

The Opportunity

Our location in Irving, TX or Abbott Park, IL currently has an opportunity for a Senior Regulatory Affairs Specialist.

What You’ll Work On

Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team.

Supports necessary regulatory activities required for product market entry and on-market support of instrument hardware and software.

Work with Regulatory and CFT to improve efficiency in regulatory deliverables.

Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to determine regulatory strategies for approval/clearance/registration for International and US markets for new products in development.

Survey the organization’s country specific regulatory experts to obtain country-specific regulatory feedback during product development and at the request of the core functional product team. Compile information to provide to core functional product teams.

Support Compliance Team in internal and external audits.

May prepare documentation needed for registration worldwide or may oversee such preparation.

Assist in SOP development and review. Provide regulatory input to product lifecycle planning.

Determine and communicate submission and approval requirements to the core functional product team.

Participate in risk benefit analysis for regulatory compliance.

Assess the acceptability of quality, preclinical and clinical documentation for submission filing.

Compile; prepare; review and submit regulatory submission to authorities (US and International).

Monitor impact of changing regulations on submission strategies.

Monitor applications under regulatory review. Communicate timelines and review status to the core functional product team.

Monitor and submit applicable reports to regulatory authorities.

Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Assess external communications relative to applicable regulations.

Review Advertising and Promotional material for compliance against regulatory requirements.

Assist with label development and review for regulatory compliance before release.

Review product changes to determine the type of change and submission requirements.

Analyze the input of cumulative product changes to current product submissions.

Ensure product safety issues and product associated events are reported to U.S. regulatory agencies.

Provide regulatory input for product recalls and recall communications.

Assess export requirements for products labeled for research or investigational use.

Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions and shares ideas freely.

Contributes to the creation of the team's mission objectives and strategies, accepts team decisions and works toward their implementation.

Required Qualifications

Bachelor's degree in science (e.g., biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy/pharmacology, nursing, engineering), engineering, or another medically related field.

Minimum 3-4 years' experience in a regulated industry (e.g., medical devices, pharmaceuticals).

2-3 years of experience in regulatory, but may consider quality assurance, research and development, product support, scientific affairs, operations, or related area.

Preferred Qualifications

Master’s degree in regulatory affairs preferred and may be considered used in lieu of direct regulatory experience. 

Advanced degree in a technical or medically related area.

Regulatory Affairs Certification (RAC).

Experience writing, compiling, and submitting FDA submissions (e.g., 510k, PMA, BLA).

Experience supporting device hardware and software.

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