Sr Regulatory Affairs Specialist (Remote)

Talentify.io; United States; Remote; USD 108,000; Full time

Job summary

An innovative firm in the diabetes technology sector is seeking a Regulatory Affairs professional to join their fully remote team. This role offers the chance to shape regulatory strategies for medical devices, ensuring compliance with US and Canadian standards. You'll be integral in preparing regulatory filings and reviewing promotional materials while enjoying a competitive salary and a supportive work environment. With a commitment to diversity and professional growth, this opportunity is perfect for someone looking to make a significant impact in the medical device industry. If you have a passion for regulatory affairs and quality assurance, this position could be your next career step.

Benefits

Competitive compensation package

Bonuses and equity

Fully remote position

Provided equipment

Virtual training

Opportunities for professional growth

Supportive work environment

Qualifications

• 5+ years of experience in Regulatory Affairs within FDA-regulated medical devices.
• Knowledge of US and Canada medical device regulations.

Responsibilities

• Prepare and maintain regulatory filings for medical device approvals.
• Develop regulatory strategies for US and Canada markets.

Skills

Regulatory Affairs

Quality Assurance

Technical Writing

Editing and Proofreading

Education

Bachelor's degree in a related technical field

Tools

Document Management Systems

eSTAR

Job description

Employer Industry: Diabetes Technology

Why consider this job opportunity:

1. Salary up to $108,000 annually
2. Competitive compensation package that includes bonuses and equity
3. Fully remote position with provided equipment and virtual training
4. Commitment to a diverse and inclusive workplace
5. Opportunities for professional growth and development
6. Supportive work environment that values employee well-being

What to Expect (Job Responsibilities):

1. Prepare and maintain domestic and international regulatory filings to meet corporate objectives
2. Develop and implement regulatory strategies for medical device approval and marketing primarily in the US and Canada
3. Review promotional materials for compliance with regulatory standards
4. Support regulatory intelligence function by tracking updates to standards and regulations globally
5. Participate in product development core teams as the regulatory representative

What is Required (Qualifications):

1. Minimum of 5 years of Regulatory Affairs / Quality Assurance experience within an FDA-regulated medical device industry
2. Demonstrated knowledge of medical device regulations in the US and Canada
3. Proficient knowledge of quality standards: ISO 13485, 21 CFR Part 820, and other industry standards
4. Bachelor's degree in a related technical field or equivalent education and applicable work experience
5. Excellent technical writing, editing, and proofreading skills

How to Stand Out (Preferred Qualifications):

1. Regulatory Affairs Certificate preferred
2. Certification (RAC) by the Regulatory Affairs Professional Society or documented training in medical device regulations
3. Experience with Diabetes insulin pumps is a plus
4. Familiarity with document management systems and electronic Submission Template And Resource (eSTAR)
5. Experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare is a plus

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