Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
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.
Requirements
- 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
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
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