Director Regulatory Affairs - Regulatory Operations and North America 155803

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.

Director Regulatory Affairs Regulatory Operations and North America (Hybrid / Onsite)

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 Canada. In 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 highperformance 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 crossfunctionally to support product development any necessary postapproval design changes. In 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.
• CrossFunctional 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 crossfunctional 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 Key Responsibilities:

• 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 priorities
• Supports 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 experience
• 5 years of experience working with business stakeholders within a crossfunctional matrix environment
• 5 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 lifecycle
• Desirable industry background includes battery operated electromechanical systems and/or wireless technology
• Experience managing a globally diverse remote team

Personal Competencies

• Excellent interpersonal communication (oral and written) teamwork leadership organizational and negotiating skills
• Writes in a clear concise organized and convincing manner for the intended audience
• Solid critical analytical and problem solving skills including consistent and effective problem solving
• Strategic Thinking: Capability to develop and implement regulatory strategies that align with organizational goals.

Nice to Have

• Must be able to work with all levels of management have the ability to influence the actions of others to ensure compliance.
• Creates a positive environment within the team and for its customers

Social Competencies

• Builds and maintains constructive working relationships characterized by high level of acceptance confidence cooperation and mutual respect
• Promotes cooperation within and outside of the team to achieve goals and deliverables
• Ability to work under pressure and meet project timelines across departments
• Effective Communication: Ability to clearly and concisely convey information to diverse audiences including regulatory bodies internal and external stakeholders

Leadership Competencies

• Strong leadership diplomatic and motivational skills including the ability to lead up across and down the business
• Proven ability to demonstrate drive for results and accountability of business needs
• Strong mentorship skills
• Flexible with proven ability to adjust to and lead a team through shifting priorities demands and timelines

Professional Competencies

• Demonstrated experience in effectively directing teams and individuals to take action and meet organizational commitments.
• Manages resources efficiently to achieve timely successful results
• Coaches team direct reports and colleagues for communication quality and trustworthiness
• Manages and resolves conflicts disagreements in a constructive manner
• Ability to manage competing priorities in a fast paced environment
• Influences motivates and challenges others

Language(s)/ Level

• English/ Fluent

Nice to Have

• Fluent in 2nd 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 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/LongTerm Disability coverage (STD/LTD)
  • STD LTD Buyups 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 roles pay range is between: $156000/yr $234000/yr (based on location). This role is also bonus eligible.

How we work:

At Sonova we prioritize the wellbeing of our employees and foster an inclusive environment that promotes engagement and collaboration. Our teamcustomized 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.