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Sonova Group · 3 days ago

Specialist II, Regulatory Affairs

Santa Clarita, CA

Full-time

Hybrid

Entry, Mid Level

$75K/yr - $113K/yr

2+ years exp

Sonova Group is a company focused on regulatory affairs in the medical device industry. The Specialist II, Regulatory Affairs role involves preparing and maintaining global regulatory submissions and ensuring compliance with worldwide regulatory requirements.

Medical Device

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

Qualification

Regulatory submissionsFDA regulationsClinical investigationsRegulatory complianceMS Office proficiencyRA certificationInterpersonal skillsCommunication skillsNegotiating skills

Required

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