Company Background:
Our client is a well-known MNC company in various technology and services industries.

Description:

The Regulatory Affairs (RA) Leader ¨C Product provides subject matter expertise. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in the area of premarket regulatory submissions and new product development.

Key responsibilities/essential functions include:

• File / maintain regulatory deliverables
• Actively participate as team member on all assigned new product introductions.
• Create regulatory compliance / project plan using Regulatory Intelligence and in collaboration with Region RA to ensure all requirements are met for country submissions; work with relevant personnel to ensure appropriate, timely input is provided for submissions. 
• Create and file submissions; communicate with authorities regarding these submissions.
• If specific country testing is needed, work with Region RA, and arrange for test devices and support as needed.
• Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.
• Review changes in existing products to determine need for new/revised submissions or document reason for no submission
• Educate, train, & advise company professionals to ensure compliance with regulatory requirements
• Communicate changes in existing products to Region RA representatives for determination of the need for new/revised licenses or registrations.
• Partner with Region RA representative for countries with license expiration requirements, to establish plan and deliverables for timely submission for renewal of license.
• Identify any clinical data requirements for product licensing globally and insure the requirements are documented in the compliance plan.
• Provide RA oversight to clinical studies.
• Support regulatory inspections as required.
• Coach or mentor other RA professionals.

Quality Specific Goals:

• Aware of and comply with the  Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility. 
• Effectively support implementation & management of current regulatory requirements within area of responsibility.
• Ensure assigned regulatory submissions are accurate, complete and timely.
  

Required Qualifications:

• Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration
• Ability to prioritize, plan & evaluate deliverables to established strategic goals.
• Proven application of analytical skills in a regulatory environment
• Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.
• Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
• Strong problem solving and negotiation skills 
• Ability to work well independently & in a team setting.     Prior experience using spreadsheet and presentation software.
• Must be willing to travel up to 10% of time.

Preferred Qualifications:

• Advanced degree in scientific, technology or legal disciplines.
• Regulatory Affairs Certification (RAPS).
• Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL. 
• Knowledge of Quality Management Systems (QMS)
• Experience with working across cultures/countries/sites 
• Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on it regulatory strategies.