Specialist, Regulatory Clinical Affairs

 

Overview

 

Clinical Affairs Specialists support regulatory clinical research through the development and design of clinical trials that meet business requirements regarding clinical data quality, timelines, and budget. The person in this role interacts with multi-disciplinary teams that span R&D, Marketing, Regulatory Affairs, and Quality. They are responsible for scoping clinical trial requirements, negotiating clinical trial designs, and preparing clinical documentation required for submission to regulatory authorities. The person in this position may engage with regulatory authorities to understand clinical data requirements that support the approval of Class III active implantable medical devices.

 

 

 

What you’ll do:

• Represent the regulatory clinical research department in product development activities

• Provide guidance to product development teams regarding global clinical requirements for clinical trials
• Develop requirements and protocols for pre-market clinical trials of Class III active implantable medical devices
• Propose clinical trial plans and budgets
• Work with regulatory affairs for the purpose of facilitating regulatory approvals and queries
• Maintain a thorough awareness of the global regulatory approvals process
• Advise the regulatory clinical research department of new developments in clinical regulations that may affect the conduct of clinical trials
• Anticipate relevant clinical obstacles and emerging issues throughout the product lifecycle and develop mitigations with input from members of clinical research and related teams
• Review and assess clinical trial regulatory documents
• Review and assess relevant scientific literature
• Write plans such as clinical development and clinical evaluation plans
• Responsible for compliance to relevant quality system requirements and regulations including ISO 14155:2020, 21 CFR Part 820, and all regulations applicable for MDSAP certification
• Other duties as assigned.

 

 

Travelling Requirement: up to 10-15%

 

 

 

What you bring to the team:

 

 

Education

•   Bachelor’s degree in a scientific discipline, engineering, audiology, or equivalent experience

Nice to Have

• Master’s degree or PhD in a Scientific Discipline
• AuD or AuD/PhD

 

 

Work Experience

• 2-5 years of experience in global clinical affairs
• Has knowledge of feasibility, pivotal, and post market clinical trials

Nice to Have

• Experience with Class III medical devices
• Background experience with methods and procedures for conducting clinical trials
• Experience working in an audiological or hearing care setting.

 

Personal Competencies

• Critical thinker, highly organized, efficient, and self-motivated
• Excellent attention to detail and the ability to multi-task projects
• Ability to work under pressure with cross-functional teams
• Capable of working independently and exercising independent judgment

Nice to Have

• Project management skills
• High learning aptitude and adaptability

 

 

Social Competencies

• Collaborative personality
• Excellent interpersonal, communication, and negotiating skills

 

 

Leadership Competencies

• Ability to communicate persuasively in a manner that supports approvals and other key company objectives

 

 

Professional Competencies

• Good working knowledge of global regulations and standards
• Excellent writing, proof reading, and data management skills
• Excellent time management and critical thinking skills

Nice to Have

• Certification by a Regulatory or Clinical Affairs Professional Society

 

 

Language(s)/ Level

• English/ Fluent  

Nice to Have

• Bilingual (e.g. Spanish, German, French)

 

 

IT Skills

• Proficient in MS Office Suite

Nice to Have

• Practical experience with smart device, PC and embedded software code.
• Familiarity with vulnerabilities of common wireless protocols such as RF, Bluetooth and Wi-Fi.
• Experience with penetration and fuzz testing

 

 

 

 

 

Our offer:

 

• Exciting and challenging work environment
• Comprehensive benefits package
• Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!

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