Senior Specialist, Regulatory Affairs - I&R (Remote)

Remote Jobs; United States; Remote; USD 100,000 - 131,000; Full time

Job summary

A leading company in the medical devices industry is seeking a Senior Specialist in Regulatory Affairs. This remote role involves developing regulatory strategies, preparing submissions for product approvals, and advising teams on compliance. The ideal candidate will have a strong background in regulatory affairs, particularly in the life sciences sector, and will contribute to a supportive company culture focused on improving patient care.

Benefits

Comprehensive medical, dental, and vision insurance

Flexible work environment

Tuition reimbursement

Wellness programs

Annual bonus opportunities

Qualifications

• Minimum of 5 years of relevant experience in regulatory affairs.
• Experience with orthopedic medical devices is preferred.

Responsibilities

• Develop regulatory strategies and implementation plans for new products.
• Prepare and submit FDA and Health Canada submissions for product approvals.
• Advise Product Development Teams on regulatory requirements.

Skills

Regulatory Affairs

Communication

Education

Bachelor's Degree

Job description

Senior Specialist, Regulatory Affairs - I&R (Remote)

Employer Industry: Medical Devices

Why consider this job opportunity:
- Salary up to $131,000
- Annual bonus opportunities available
- Comprehensive medical, dental, and vision insurance
- Flexible work environment with the ability to work remotely from anywhere in the United States
- Opportunities for professional development, including tuition reimbursement and wellness programs
- Supportive company culture focused on helping surgeons treat their patients better

What to Expect (Job Responsibilities):
- Develop regulatory strategies and implementation plans for new products in the U.S., EU, and Canada
- Prepare and submit FDA, Notified Body, and Health Canada submissions for product approvals
- Advise Product Development Teams on regulatory requirements and documentation needed for submissions
- Review and approve design control documentation and engineering change requests for compliance
- Maintain positive relationships with regulatory agency personnel and provide ongoing support for marketed products

What is Required (Qualifications):
- Minimum of 5 years of relevant experience in regulatory affairs, preferably in the life sciences industry
- Bachelor's degree required; engineering or science discipline preferred
- Experience with orthopedic medical devices is preferred
- Proficiency in regulatory submissions and knowledge of IEC standards preferred
- Ability to communicate effectively both verbally and in writing

How to Stand Out (Preferred Qualifications):
- Advanced degree in a relevant field
- Regulatory Affairs Certification (RAC)
- Experience in authoring and submitting medical device registrations
- Familiarity with product labeling and advertising for medical devices
- Working knowledge of IEC 60601-1, IEC 62304, and EU RoHS/REACH

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