Experience with Regulatory and Clinical Submissions: This involves developing, writing, and editing regulatory and clinical submissions, such as FDA PMA applications, IDE Progress Reports, and EU technical files.
Knowledge of US and EU Medical Device Regulations: Understanding the regulatory requirements for medical devices in both the United States and the European Union.
Negotiation and Conflict Resolution Skills: Demonstrated abilities in negotiation and resolving conflicts.
Quick Learning in New Therapeutic Areas: The ability to rapidly learn and adapt to new therapeutic fields
Day to Day:
The Senior Regulatory Specialist oversees the assembly of EU MDR technical documentation, scrutinizes materials related to product development, and formulates regulatory filings for active implantable medical devices within the Neuromodulation Business Unit. This pivotal position requires effective liaison with different sectors of the organization to ensure clear communication and teamwork in achieving project milestones while adhering strictly to regulatory standards. Commitment to upholding our organization’s core values and strategic objectives is essential for this role.
Compensation:
$40/hr to $60/hr.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Medical Equipment Manufacturing
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