Specialist Regulatory Affairs

• 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.

• Bachelor's degree in science (e.g., biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy/pharmacology, nursing, engineering), or another medically related field.
• 2-3 years of experience in a regulated industry (e.g., medical devices, pharmaceuticals). Regulatory area is preferred but may consider quality assurance, research and development, product support, scientific affairs, operations, or related area.

• Master’s degree in regulatory affairs may be considered 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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In specific locations, the pay range may vary from the range posted.