Director, Regulatory Affairs - Regulatory Operations and North America Job Details | Sonova AG

About the position

As the Director, Regulatory Affairs - Regulatory Operations and North America for Advanced Bionics, you will play a critical leadership role in guiding the regulatory team in navigating complex regulatory landscapes and ensuring compliance with all applicable regulations of active implantable medical devices. Your expertise will contribute to creating and executing successful strategies for regulatory submissions, ensuring on time product approvals.

Responsibilities
? Develop and implement comprehensive regulatory strategies to support the development, approval, and marketing of Class III medical devices primarily in the US and Canada.
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? Ensure that the company's products comply with regulatory standards (FDA, EU MDR, and other international regulations) throughout the product lifecycle.
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? Lead the preparation, submission, and maintenance of regulatory filings for the US and Canada.
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? Prepare or direct regulatory affairs staff in the generation of applications (i.e., IDE) for conducting clinical investigations.
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? Generate/Oversee required submissions (progress reports, etc.) to support the continuation of clinical studies.
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? Manage and mentor a team of regulatory professionals, fostering professional growth and promoting a high-performance culture.
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? Provide strategic leadership and guidance to RA team members embedded in project core teams.
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? Work closely with R&D, Quality Assurance, Marketing, and Manufacturing teams to align regulatory strategies with business objectives.
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? Develop risk mitigation strategies related to regulatory compliance, audits, and product approvals.
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? Collaborate cross functionally to ensure compliance with global medical device labeling regulations.
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? Lead the process for ensuring comprehensive compliance framework for assessing and integrating external standards and regulatory changes.
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? Act as the primary liaison with regulatory authorities, managing relationships and communications with agencies such as the FDA, Notified Bodies, and Health Canada.
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? Stay abreast of evolving global regulatory requirements and implement changes within the organization as needed.

Requirements
? Bachelor's Degree in Regulatory Affairs or scientific discipline
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? Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance)
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? 8+ years of progressive management experience
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? 5+ years of experience working with business stakeholders within a cross-functional matrix environment
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? 5+ years Class III Medical Device Company in Regulatory Affairs

Nice-to-haves
? Advanced Degree in Regulatory Affairs
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? RA certification (by Regulatory Affairs Professional Society)
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? Coursework, seminars, and/or other formal trade association training required
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? Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycle
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? Desirable industry background includes battery operated electromechanical systems and/or wireless technology
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? Experience managing a globally diverse, remote team
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? Fluent in 2nd language
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? Experience with collaboration tools, JIRA, SharePoint
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? Experience with SAP

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

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