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

Arthrex; Naples (FL); Remote; USD 90,000 - 131,000; Full time

Job summary

An established industry player in medical device manufacturing is seeking a skilled regulatory affairs professional. This remote opportunity offers a competitive salary and a comprehensive benefits package, including medical, dental, and vision insurance. You will play a crucial role in developing regulatory strategies, advising product teams on compliance, and maintaining relationships with regulatory agencies. If you have a strong background in regulatory submissions and a passion for the life sciences industry, this position offers the chance for career advancement and personal growth within a supportive environment.

Benefits

Comprehensive benefits package

Annual bonus

401(k) matching

Tuition reimbursement

Wellness incentive programs

Qualifications

• 5+ years in regulatory affairs in life sciences.
• Experience with orthopedic medical devices preferred.

Responsibilities

• Develop regulatory strategies for new products.
• Prepare and submit regulatory documentation for compliance.
• Maintain relationships with regulatory agency personnel.

Skills

Regulatory submissions

Communication skills

Knowledge of IEC standards

Education

Bachelor's degree in engineering or science

Advanced degree in a relevant field

Job description

Employer Industry: Medical Device Manufacturing

Why consider this job opportunity:
- Salary up to $131,000
- Opportunity for career advancement and growth within the organization
- Work remotely anywhere within the United States
- Comprehensive benefits package, including medical, dental, and vision insurance
- Annual bonus and matching 401(k) retirement plan
- Tuition reimbursement and wellness incentive programs

What to Expect (Job Responsibilities):
- Develop regulatory strategies and implementation plans for new products in the U.S., EU, and Canada
- Advise product development teams on regulatory requirements and documentation for FDA and Health Canada submissions
- Prepare and submit regulatory documentation to ensure compliance and timely approvals
- Review design control documentation and engineering change requests for compliance with global regulations
- 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 a regulatory affairs role in the life sciences industry
- Bachelor’s degree required; engineering or science discipline preferred
- Experience with orthopedic medical devices preferred
- Proficiency in regulatory submissions and knowledge of IEC standards preferred
- Strong written and verbal communication skills

How to Stand Out (Preferred Qualifications):
- Advanced degree in a relevant field
- Regulatory Affairs Certification (RAC)
- Experience 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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