Specialist, Regulatory Affairs Operations

Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands – Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron – we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

 

Specialist, Regulatory Affairs Operations (Hybrid OR Remote)

 

The Regulatory Affairs Professional provides support to the team and gathers information required for monitoring regulatory requirements.

Support Regulatory Affairs operations activities for Class III active implantable medical devices.  Participate in activities to ensure compliance with global regulatory requirements and standards throughout the product lifecycle. 

 

 

Responsibilities:

• Maintain an awareness of new and developing legislations, regulatory policy, regulatory guidance and international standards relating to Advanced Bionics.
• Monitor and communicate impact of relevant regulations, guidance documents, and international standards.
• Support business efforts to comply with new and existing regulations and international standards.
• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.
• Maintain and update assigned standard operating procedures, policies and work instructions.
• Support training, troubleshooting, and problem resolution for Regulatory Affairs systems and procedures.
• Foster relationships across business units and functional groups to share best practices.
• Identify opportunities for process improvement and participate in projects as a subject matter expert.
• Lead and support special projects including, but not limited to, data analysis and system implementations.

Additional Key Responsibilities:

• Support UDI, Regulatory Agency Audits, and Field Action activities, as required.
• Other duties as assigned.

 

Travelling Requirement: Up to 20%

 

 

More about you:

Education

• Bachelor’s Degree in in scientific discipline / engineering or equivalent.

Nice to Have

• Advanced Degree in scientific discipline / engineering / Management.

 

 

Work Experience

• Minimum of 4 years’ experience in regulatory affairs, quality assurance, compliance, or project management for Class III active implantable medical devices.