Regulatory Affairs Manager

• Location: Austin
• Type: Direct Hire
• Job #36962

Regulatory Affairs Manager
Austin, TX

Exciting new opportunity with a rapidly growing biotech research company, is a leader in the manufacturing, processing, and distribution of medical devices. This is perfect for an experienced Regulatory Affairs professional with a Bachelors Degree in science, engineering, or related field, with 7-10 years of regulatory experience.

Salary: $100-120k/yr. + bonus
Terms: Direct Hire

The Manager, Regulatory Affairs, in collaboration with more senior RA Management, will work directly with the Food and Drug Administration (FDA)and other domestic and international regulatory agencies to obtain and maintain regulatory approvals and compliance for medical devices. This role will collaborate with global stakeholders (e.g. R&D, Quality, Clinical, Marketing, Operations) as a core team member, and will manage junior staff and cross-functional or matrix teams as appropriate.

Responsibilities

• Represent the Austin facility with responsibility for regulatory compliance and management of local RA staff, as assigned.
• Accountable for development and execution of regulatory strategies and submission activities (510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian License, international registrations, including amendments, supplements, renewals, annual reports and responses to requests for additional information) for complex new product development activities and product maintenance for existing approved products.
• Team with global partners and international regulatory staff to provide support for new products/therapies and changes to existing products. Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies.
• Review significant product submissions with project stakeholders and negotiate submission issues with agency personnel. Ensure timely submission approvals and product market release.
• Provide support to currently marketed products, including review of labeling, promotional material, product changes and documentation for changes, facility site registrations, audits, etc., as needed.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel, and collaborate with RA personnel to implement regulatory changes to regulatory documentation and procedures.
• Provide feedback and on-going support to staff and product development teams for regulatory issues and questions, and ensure quality system compliance and high-quality work outcomes.
• Create, maintain and update regulatory processes and SOPs and ensure local site compliance, and support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)

Required

• Bachelor’s degree in science, engineering or related field, with 7-10 years of regulatory experience.
• Experience with FDA Class II or III devices or experience with EU Class IIa/IIb or III devices
• Strong analytical, technical writing, communication, organizational, time management, and interpersonal relationship skills
• Awareness of global regulatory affairs, product development and total product lifecycle processes
• Ability to comprehend principles of engineering, physiology, and medical device use
• Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects
• Ability to effectively manage and prioritize numerous projects in a fast-paced environment
• Expertise in Microsoft Office Suite

Preferred

• Experience with US FDA correspondence, TGA and Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue
• Experience leading cross-functional teams with some prior management experience

**This job description is a complete list of all desired skills but not all are required.  We strongly encourage candidates who have some of the skills to apply.  We look forward to a conversation to learn more about you**