Specialist, Regulatory Affairs Operations

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.

Specialist, Regulatory Affairs Operations (Hybrid OR Remote)

Support Regulatory Affairs operations activities for Class III active implantable medical devices. Participate in activities to ensure compliance with global regulatory requirements and standards throughout the product lifecycle.

• Maintain an awareness of new and developing legislations, regulatory policy, regulatory guidance and international standards relating to Advanced Bionics.
• Monitor and communicate impact of relevant regulations, guidance documents, and international standards.
• Support business efforts to comply with new and existing regulations and international standards.
• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.
• Maintain and update assigned standard operating procedures, policies and work instructions.
• Support training, troubleshooting, and problem resolution for Regulatory Affairs systems and procedures.
• Foster relationships across business units and functional groups to share best practices.
• Identify opportunities for process improvement and participate in projects as a subject matter expert.
• Lead and support special projects including, but not limited to, data analysis and system implementations.

• Support UDI, Regulatory Agency Audits, and Field Action activities, as required.
• Other duties as assigned.

Travelling Requirement: Up to 20%

More about you: Education

• Bachelor’s Degree in in scientific discipline / engineering or equivalent.

• Advanced Degree in scientific discipline / engineering / Management.

• Minimum of 4 years’ experience in regulatory affairs, quality assurance, compliance, or project management for Class III active implantable medical devices.

• 6+ years’ experience in global regulatory affairs or compliance for Class III active implantable medical devices.

• Motivated self-starter with the ability to perform independently or in teams in a fast-paced environment in response to business-critical assignments.

• High learning aptitude and adaptability with systems and regulatory landscape.

• Team player who seeks to help and learn from colleagues.
• Excellent interpersonal and communication skills.

• Good working knowledge of Global requirements, regulations and standards for Class III active implantable medical devices.
• Ability to work effectively in a matrix organization and partner effectively with remote stakeholders and peers
• Excellent writing, proof reading and data management skills.
• Excellent time management and problem-solving skills.

• Experience using Continuous Improvement methodologies, for example Six Sigma and statistical tools for data analysis

• English/ Proficient

• Proficient in 2nd language

• Proficient with Microsoft Office suite.
• Working knowledge of cloud based systems.
• Ability to quickly learn new computer technology software packages with minimal training

• Oracle, SAP and Salesforce experience.
• Adobe InDesign experience.

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

• 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: $64,000/yr - $96,000/yr (based on location). This role is also bonus eligible.

We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

=== Company description

Medical Device Class III Manufacturer.