Senior Specialist, International Regulatory Affairs

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.

Senior Specialist, International Regulatory Affairs (Hybrid OR Remote)

The Senior Professional Regulatory Affairs implements and monitors regulatory programs and assists in the homologation of the product range.

Responsibilities:

The Senior Regulatory Affairs (RA) Specialist - International will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within International markets.

• This position ensures compliance with required global regulations and serves as a key team member and/or in a lead role on extended team(s).
• Develop and execute global regulatory activities necessary to obtain and maintain regulatory approvals in international markets (such as, LATAM, EMEA, APAC and Canada).
• Provide support to local In-country RA affiliates who interact with regulatory authorities to assure timely approvals and continued product access.
• Prepare submissions, interact effectively with regulatory agencies and negotiate submission issues as needed.
• Participate and represent OUS regulatory function in sustaining and new product development projects to provide OUS regulatory requirements.
• Assist in keeping company informed of regulatory requirements and external standards in international markets.
• Prepares International submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.
• Supports International product demand planning and release activities.
• Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.
• Supports post market regulatory compliance activities for international product approvals.
• Develops and maintains regulatory affairs department procedures and process improvements.
• Other duties as assigned or required.

Additional Key Responsibilities:

• Provides input to assure that applicable country regulatory requirements including EU MDR regulations and standards are incorporated in the product development process and design/ manufacture of the products.
• Review and assess the RA inputs document in order to discuss the project and its scope and determine country-specific requirements such as testing requirements, labeling requirements as part of the Regulatory Inputs Documents.
• Produce subsequent submissions (License Renewals, Annual Reports, Additional Information Requests, etc.) to facilitate the maintenance of th