Senior Specialist, International Regulatory Affairs Job Details | Sonova AG

$80,800 - $121,200/Yr

Sonova - Valencia, CA

Full-time - Senior

Hybrid - Valencia, CA

Computer and Electronic Product Manufacturing

About the position

The Senior Professional Regulatory Affairs implements and monitors regulatory programs and assists in the homologation of the product range. The Senior Regulatory Affairs (RA) Specialist - International will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within International markets. This position ensures compliance with required global regulations and serves as a key team member and/or in a lead role on extended team(s).

Responsibilities

• Plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals in international markets (such as, LATAM, EMEA, APAC and Canada).
• Provide support to local In-country RA affiliates who interact with regulatory authorities to assure timely approvals and continued product access.
• Prepare submissions, interact effectively with regulatory agencies and negotiate submission issues as needed.
• Participate and represent OUS regulatory function in sustaining and new product development projects to provide OUS regulatory requirements.
• Assist in keeping company informed of regulatory requirements and external standards in international markets.
• Prepare International submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.
• Support International product demand planning and release activities.
• Review Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.
• Support post market regulatory compliance activities for international product approvals.
• Develop and maintain regulatory affairs department procedures and process improvements.

Requirements

• Bachelor's Degree (and/or 8-10 years of equivalent work experience)
• 5-8 years of experience in pre/post market medical device regulatory affairs
• Experience in global regulations and maintaining certifications for the life of a medical device
• Experience leading cross-functional teams
• Experience providing regulatory strategy and guidance for Outside US and EU markets, (MENA, APAC, LATAM)

Nice-to-haves

• Bachelor's degree in a technical or scientific field (e.g., Biochemistry, Biomedical, Electrical, or Chemical Engineering), or equivalent practical experience
• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Experience interacting with regulators during the market approval process.
• Experience providing regulatory support for products under development (e.g., classification assessments, review engineering documents, risk analyses, test protocols and reports).

Benefits

• 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