About the role

Specialist II in Regulatory Affairs preparing and maintaining global submissions for conducting clinical investigations. Collaborating with engineering and regulatory teams to ensure compliance with worldwide regulations.

Responsibilities

Prepare and maintain global regulatory submissions (e.g., PMAs, PMA supplements, CE Mark applications, product registrations, annual reports, and change notifications) to obtain and sustain worldwide product approvals.
Partner with Clinical Research to prepare and support clinical investigation submissions (e.g., IDEs) and ongoing regulatory documentation for studies conducted in the U.S., Canada, and EU.
Manage and submit required reports for complaint handling and postmarket surveillance and vigilance activities, serving as lead for the Complaint Handling Group as needed.
Provide regulatory guidance to engineering and manufacturing teams to ensure compliance with global regulatory requirements throughout product design, development, and manufacturing.
Participate in engineering change order processes by reviewing and approving engineering and manufacturing documentation and changes.
Review and provide regulatory input on product labeling and marketing materials to ensure alignment with applicable regulations and standards.
Monitor evolving regulatory requirements and participate in cross-functional governance bodies (e.g., Safety Review Board and Patient Management Review Board), advising Regulatory Affairs leadership as appropriate.

Required a bachelor’s degree, preferably in scientific discipline or engineering
Required 2 - 3 years of experience in the area of worldwide regulatory affairs (both submissions and compliance) at medical device companies, preferably under the Class III medical device environment
Proficiency with MS Outlook, Word, Excel, PowerPoint, Access and SQL
Good working knowledge of U.S. FDA, Canada and EU regulations and standards
Excellent interpersonal, communication and negotiating skills
RA certification (by Regulatory Affairs Professional Society) is a plus
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

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