Specialist, Regulatory Clinical Affairs

1 week ago

Valencia, United States Sonova AG Full time

Class III Medical Device Manufacturer

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
Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you
We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

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