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 these approvals.
• In conjunction with Clinical Research, help in the preparation of applications (i.e. IDE) for conducting clinical investigations, as required. Generate required submissions (progress reports, etc.) to support the continuation of clinical studies.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Ensure compliance with pre-market and post-market approval requirements.
• Contributes to the development or the RA budget by forecasting resource needs, estimating costs for submissions, recertifications and compliance activities and aligning financial planning the strategic regulatory objectives.  Once budget is set, manages within plan and escalates if/when issues arise.

Travelling Requirement: Up to 10%

More about you:

Education

• Bachelor’s Degree (and/or 8-10 years of equivalent work experience)

Nice to Have

• Bachelor's degree in a technical or scientific field (e.g., Biochemistry, Biomedical, Electrical, or Chemical Engineering), or equivalent practical experience

Further Education

Nice to Have

• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

Work Experience

• 5-8 years of experience in pre/post market medical device regulatory affairs
• Experience in global regulations and maintaining certifications for the life of a medical device
• Experience leading cross-functional teams
• Experience providing regulatory strategy and guidance for Outside US and EU markets, (MENA, APAC, LATAM)

Nice to Have

• Experience interacting with regulators during the market approval process.
• Experience providing regulatory support for products under development (e.g., classification assessments, review engineering documents, risk analyses, test protocols and reports).

Personal Competencies

• Good working knowledge of Global regulations and standards.
• Excellent writing, proof reading and data management skills
• Excellent time management and problem solving skills
• Ability to adapt to different roles, responsibilities and context.
• Ability to change priorities and direction when necessary.

Social Competencies

• Work effectively in a team setting, collaborative
• Value transparency, honesty and work ethics and apply them in relationships and own work
• Admit faults and seek guidance as necessary
• Be open-minded, objective, and accountable for own actions
• Be reliable and trustworthy

Leadership Competencies

• Uses effective strategies to facilitate organizational change initiatives and overcome resistance to change
• Uses effective career management tactics, including mentoring, professional relationships, and feedback channels

Professional Competencies

• Ability to work independently
• Ability to manage time effectively and independently
• Ability to prioritize among multiple projects, tasks, and duties
• Ability to manage pressures, distractions and stress

Language(s)/ Level

• English/ Fluent  (spoken, written)

Nice to Have

• Fluency in languages, including French/Farsi or others

IT Skills

• Proficient in Microsoft Office Suite

Nice to Have

• Experience with Agile PLM, SAP and Regulatory Information Management Systems.

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

 What we offer:

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
  • Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform
• D&I focused: D&I council and employee resource groups

*Plan rules/offerings dependent upon group Company/location.

This role's pay range is between: $80,800/yr - $121,200/yr (based on location). This role is also bonus eligible. 

How we work:

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.