Senior Regulatory Affairs Specialist, Program Lead

Remote Jobs; United States; Remote; USD 136,000 - 160,000; Full time

Job summary

A leading company in Healthcare Innovation seeks a Senior Regulatory Affairs Specialist to manage regulatory submissions and support product development. The role offers a competitive salary up to $160,000, comprehensive benefits, and opportunities for career advancement. Flexible telecommuting options and generous time-off benefits are included.

Benefits

Comprehensive benefits package including medical, dental, and vision

Annual performance bonus

Flexible telecommuting options

Generous time off benefits

Qualifications

• Minimum 4 years of experience in regulatory affairs or related occupation.
• Proven expertise in regulatory submissions and device approvals.
• Strong understanding of regulatory requirements.

Responsibilities

• Author regulatory submissions and support product development for approvals.
• Manage and submit required regulatory registrations.
• Collaborate on regulatory approval efforts with international colleagues.

Skills

Excellent communication

Collaboration skills

Regulatory compliance

Education

Master's degree in Pharmacy Administration or Biomechanical Engineering

Job description

Employer Industry: Healthcare Innovation and Medical Technology

Why consider this job opportunity:
- Salary up to $160,000 annually
- Eligible for an annual performance bonus based on individual and company performance
- Comprehensive benefits package including medical, dental, vision, life insurance, and more
- Opportunities for career advancement and involvement in innovative healthcare solutions
- Flexible telecommuting options available
- Generous time off benefits, including vacation and holiday pay

What to Expect (Job Responsibilities):
- Author regulatory submissions and support product development stages to achieve US and international regulatory approval goals
- Manage, prepare, and submit regulatory submissions required for device approvals and registrations
- Collaborate with international colleagues on regulatory approval efforts
- Conduct regulatory evaluations of changes to devices and generate necessary regulatory submissions
- Provide expert regulatory feedback on specifications, device testing, and risk management documentation

What is Required (Qualifications):
- Master's degree in Pharmacy Administration, Biomechanical Engineering, or a related field
- Minimum of 4 years of experience in regulatory affairs or a related occupation
- Proven expertise in regulatory submissions and device approvals
- Strong understanding of regulatory requirements and compliance
- Excellent communication and collaboration skills

How to Stand Out (Preferred Qualifications):
- Experience as a Senior Regulatory Affairs Specialist or in a similar program lead role
- Familiarity with international regulatory standards and processes
- Background in clinical research and evaluations
- Ability to simplify complex problems into manageable tasks
- Experience with quality system and technical file audits

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