PURPOSE OF THEPOSITION:

Provide technical leadership in the development and implementation of scientifically-robust regulatory strategies to support business objectives, while ensuring compliance with domestic and international device, and personal protective equipment regulations. Provide consultation to support development and implementation of quality management systems. Help refine and maintain systems that support regulatory compliance and for retrieving and organizing regulatory related information.

RESPONSIBILITIES(FUNDAMENTAL JOB DUTIES):

1. Develop international regulatory strategies and corresponding submissions in support of business objectives
2. Ensure that international regulatory submissions are prepared and submitted accurately, completely and in a timely manner to meet business objectives
3. Maintainregulatoryaffairsfiles(e.g., establishment registrations and device listings, quality certificates, and device/facility licenses) and distribute information as required to support key stakeholders
4. Participateinthereviewofprocess/product changes, labeling, complaints,etc.,to determine the need for any regulatory activities and to ensure compliance with international requirements
5. Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective action
6. Support and participate in audits performed by internal and external (e.g., MDSAP, Notified Body,etc.) representatives
7. Assist global sales and marketing with regulatory registration requirements
8. Support the implementation of regulatory activities throughout the Halyard Irvine facility
9. Assist in preparation and execution of Field Action activities
10. Follow-up, track and assemble regulatory commitments to Agencies as required
11. Perform other responsibilities, as assigned

REPORTING RELATIONSHIPS:

Reports to: Associate Director of Regulatory Affairs

JOBREQUIREMENTS:

EDUCATION: Minimum of bachelor’s degree in a scientific discipline or equivalent.

EXPERIENCE REQUIREMENTS:

-3-5 years’ relevant experience in Class II and/or Class III Medical device industry including global or domestic regulatory submission support

-Exceptional written and verbal communication skills

-Team player with excellent organizational skills

-Ability to multi-task effectively and work efficiently within a strict timeline-driven environment

PREFERREDQUALIFICATIONS:

-Software and electromechanical regulatory experience

-Strong knowledge of domestic and international medical device laws and regulations

-FDAQSR, MDD93/42/EEC, ISO13485, CMDR

-Regulatory Affairs Certification (RAC)

INTERNAL INTERFACE:

All Departments within the Organization

EXTERNAL INTERFACE:

FDA, Notified Bodies, Ministries of Health, Third-Party Agencies and other applicable domestic and international government agencies