Sonova International
Director, Regulatory Affairs - Regulatory Operations and North America
Sonova International, Santa Clarita, California, United States, 91382
Who we are
You could be just the right applicant for this job Read all associated information and make sure to apply. 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. Valencia CA Hybrid Director Regulatory Affairs Regulatory Operations North America 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 : Regulatory Strategy : Develop and implement comprehensive regulatory strategies to support the development approval and marketing of Class III medical devices primarily in the US and Canada. Compliance Oversight : Ensure that the companys products comply with regulatory standards (FDA EU MDR and other international regulations) throughout the product lifecycle. Submissions and Approvals : Lead the preparation submission and maintenance of regulatory filings for the US and conjunction with Clinical Research prepare or direct regulatory affairs staff in the generation of applications (i.e. IDE) for conducting clinical investigations. Generate / Oversee required submissions (progress reports etc.) to support the continuation of clinical studies. Team Leadership : Manage and mentor a team of regulatory professionals fostering professional growth and promoting a high-performance culture. Includes providing strategic leadership and guidance to RA team members embedded in project core teams ensuring they effectively represent global regulatory requirements manage timelines for submissions and approvals and collaborate cross-functionally to support product development any necessary post-approval design addition is responsible for ensuring compliance with all employment regulations requirements and perfromance expectations. This includes the development of direct reports and team members through the use of Performance Objectives training and development plans Performance Appraisals merit processes and Performance Management Plans to ensure success of the team. Cross-Functional Collaboration : Work closely with R&D Quality Assurance Marketing and Manufacturing teams to align regulatory strategies with business objectives. Risk Management : Develop risk mitigation strategies related to regulatory compliance audits and product approvals. Lead responses to regulatory inquiries and inspection readiness activities. Product Labeling : Collaborate cross functionally to ensure compliance with global medical device labeling regulations by overseeing the creation and maintenance of all product labeling according to relevant standards and country specific requirements. Regulation and Standards Compliance : Leads the process for ensuring comprehensive compliance framework for assessing and integrating external standards and regulatory changes ensuring alignment across cross-functional teams and driving proactive procedural updates. Stakeholder Management : Act as the primary liaison with regulatory authorities managing relationships and communications with agencies such as the FDA Notified Bodies and Health Canada. Change Management : Stay abreast of evolving global regulatory requirements and implement changes within the organization as needed ensuring continuous compliance. Additional Requirements : Oversees any field corrective actions.Supports management with implementation of departmental strategies and company policies.Collaborates with cross functional teams to resolve complex project issues.Effectively plans and organizes teams work to ensure company objectives are met.Creates relationships with cross functional teams to ensure regulatory operational activities are in line with global business prioritiesSupports regulatory agency audits as required.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.Other duties as assigned. Travelling Requirement : Up to 10% More about you : Education Bachelors Degree in Regulatory Affairs or scientific discipline
Nice to Have Advanced Degree in Regulatory Affairs
Further Education RA certification (by Regulatory Affairs Professional Society)
Nice to Have Coursework seminars and / or other formal trade association training required
Work Experience Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance)8 years of progressive management experience5 years of experience working with business stakeholders within a cross-functional matrix environment5 years Class III Medical Device Company in Regulatory Affairs
Nice to Have Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycleDesirable industry background includes battery operated electromechanical systems and / or wireless technologyExperience managing a globally diverse remote team
Leadership Competencies Strong leadership diplomatic and motivational skills including the ability to lead up across and down the businessProven ability to demonstrate drive for results and accountability of business needsStrong mentorship skillsFlexible with proven ability to adjust to and lead a team through shifting priorities demands and timelines
Language(s) / Level English / Fluent
Nice to Have Fluent in a second language
IT Skills : Proficient in Microsoft Office / including Word Excel Adobe Acrobat writer and Visio
Nice to Have Experience with collaboration tools JIRA SharePoint Experience with SAP A minimum of 200Mb / sec download and 10Mb / sec upload speed internet connectivity is required to support any remote / hybrid employee functionality at Sonova Dont meet all the criteria If youre willing to go allin and learn wed love to hear from you! What we offer : Medical dental and vision coverageHealth Savings Health Reimbursement Flexible Spending / Dependent Care AccountsTeleHealth options401k plan with company matchCompany 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 coverageLegal / ID Theft AssistancePTO (or sick and vacation time) floating Diversity Day & paid holidaysPaid parental bonding leaveEmployee Assistance Program (24 / 7 mental health support hotline 5 company paid counseling sessions and more)Robust Internal Career Growth opportunitiesTuition reimbursementHearing aid discount for employees and familyInternal social recognition platformD&I focused : D&I council and employee resource groupsPlan rules / offerings dependent upon group Company / location . This roles pay range is between $169600 / yr - $212000 / yr (based on location). This role is also eligible for bonus. 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. Required Experience : Director Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type :
Full-Time Experience :
years Vacancy :
1
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You could be just the right applicant for this job Read all associated information and make sure to apply. 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. Valencia CA Hybrid Director Regulatory Affairs Regulatory Operations North America 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 : Regulatory Strategy : Develop and implement comprehensive regulatory strategies to support the development approval and marketing of Class III medical devices primarily in the US and Canada. Compliance Oversight : Ensure that the companys products comply with regulatory standards (FDA EU MDR and other international regulations) throughout the product lifecycle. Submissions and Approvals : Lead the preparation submission and maintenance of regulatory filings for the US and conjunction with Clinical Research prepare or direct regulatory affairs staff in the generation of applications (i.e. IDE) for conducting clinical investigations. Generate / Oversee required submissions (progress reports etc.) to support the continuation of clinical studies. Team Leadership : Manage and mentor a team of regulatory professionals fostering professional growth and promoting a high-performance culture. Includes providing strategic leadership and guidance to RA team members embedded in project core teams ensuring they effectively represent global regulatory requirements manage timelines for submissions and approvals and collaborate cross-functionally to support product development any necessary post-approval design addition is responsible for ensuring compliance with all employment regulations requirements and perfromance expectations. This includes the development of direct reports and team members through the use of Performance Objectives training and development plans Performance Appraisals merit processes and Performance Management Plans to ensure success of the team. Cross-Functional Collaboration : Work closely with R&D Quality Assurance Marketing and Manufacturing teams to align regulatory strategies with business objectives. Risk Management : Develop risk mitigation strategies related to regulatory compliance audits and product approvals. Lead responses to regulatory inquiries and inspection readiness activities. Product Labeling : Collaborate cross functionally to ensure compliance with global medical device labeling regulations by overseeing the creation and maintenance of all product labeling according to relevant standards and country specific requirements. Regulation and Standards Compliance : Leads the process for ensuring comprehensive compliance framework for assessing and integrating external standards and regulatory changes ensuring alignment across cross-functional teams and driving proactive procedural updates. Stakeholder Management : Act as the primary liaison with regulatory authorities managing relationships and communications with agencies such as the FDA Notified Bodies and Health Canada. Change Management : Stay abreast of evolving global regulatory requirements and implement changes within the organization as needed ensuring continuous compliance. Additional Requirements : Oversees any field corrective actions.Supports management with implementation of departmental strategies and company policies.Collaborates with cross functional teams to resolve complex project issues.Effectively plans and organizes teams work to ensure company objectives are met.Creates relationships with cross functional teams to ensure regulatory operational activities are in line with global business prioritiesSupports regulatory agency audits as required.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.Other duties as assigned. Travelling Requirement : Up to 10% More about you : Education Bachelors Degree in Regulatory Affairs or scientific discipline
Nice to Have Advanced Degree in Regulatory Affairs
Further Education RA certification (by Regulatory Affairs Professional Society)
Nice to Have Coursework seminars and / or other formal trade association training required
Work Experience Minimum of 12 years of experience in the area of international regulatory affairs (both submissions and compliance)8 years of progressive management experience5 years of experience working with business stakeholders within a cross-functional matrix environment5 years Class III Medical Device Company in Regulatory Affairs
Nice to Have Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycleDesirable industry background includes battery operated electromechanical systems and / or wireless technologyExperience managing a globally diverse remote team
Leadership Competencies Strong leadership diplomatic and motivational skills including the ability to lead up across and down the businessProven ability to demonstrate drive for results and accountability of business needsStrong mentorship skillsFlexible with proven ability to adjust to and lead a team through shifting priorities demands and timelines
Language(s) / Level English / Fluent
Nice to Have Fluent in a second language
IT Skills : Proficient in Microsoft Office / including Word Excel Adobe Acrobat writer and Visio
Nice to Have Experience with collaboration tools JIRA SharePoint Experience with SAP A minimum of 200Mb / sec download and 10Mb / sec upload speed internet connectivity is required to support any remote / hybrid employee functionality at Sonova Dont meet all the criteria If youre willing to go allin and learn wed love to hear from you! What we offer : Medical dental and vision coverageHealth Savings Health Reimbursement Flexible Spending / Dependent Care AccountsTeleHealth options401k plan with company matchCompany 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 coverageLegal / ID Theft AssistancePTO (or sick and vacation time) floating Diversity Day & paid holidaysPaid parental bonding leaveEmployee Assistance Program (24 / 7 mental health support hotline 5 company paid counseling sessions and more)Robust Internal Career Growth opportunitiesTuition reimbursementHearing aid discount for employees and familyInternal social recognition platformD&I focused : D&I council and employee resource groupsPlan rules / offerings dependent upon group Company / location . This roles pay range is between $169600 / yr - $212000 / yr (based on location). This role is also eligible for bonus. 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. Required Experience : Director Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type :
Full-Time Experience :
years Vacancy :
1
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