Senior Regulatory Affairs Specialist

BioPhase; United States; Remote; USD 100,000 - 125,000; Part time

Job summary

A leading Life Sciences company is seeking a Temporary Staff Regulatory Affairs Specialist to manage regulatory submissions and compliance for medical devices. This remote position involves preparing documentation, conducting assessments, and collaborating with multiple departments to ensure product compliance in a fast-paced environment.

Benefits

Career development resources

Diverse and inclusive community

Qualifications

• 6+ years in Regulatory Affairs, with 4+ years in IVD Regulatory Affairs.
• Experience with 510(k) submissions and IVDR compliance.
• Strong knowledge of IVD regulations and ISO standards.

Responsibilities

• Prepare and submit regulatory submissions like 510(k) and IVDR Technical Documentation.
• Conduct regulatory assessments and collaborate with various teams.
• Monitor global regulatory trends and assess their impact.

Skills

Regulatory Assessments

Compliance Management

Communication Skills

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Advanced degree preferred

Job description

This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $62.00/hr

Direct message the job poster from BioPhase

Senior HR & Admin Recruiter @ BioPhase | Life Sciences

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community. We are currently looking for a REMOTE Temporary Staff Regulatory Affairs Specialist for a leading San Diego area medical device/diagnostic company.

Responsibilities

• Prepare and submit 510(k), IVDR Technical Documentation, and other regulatory submissions.

• Conduct regulatory assessments for product changes and compliance.

• Collaborate with R&D, Quality, Manufacturing, and Marketing teams.

• Monitor global regulatory trends and assess their impact on product compliance.

• Review and approve product labeling, advertising, and promotional materials.

• Maintain regulatory documentation and support market authorizations.

• Assist with regulatory inspections, audits, and compliance initiatives.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field (Advanced degree preferred).

• 6+ years in Regulatory Affairs, with 4+ years in IVD Regulatory Affairs.

• Experience with 510(k) submissions, IVDR compliance, and global registrations.

• Strong knowledge of IVD regulations, ISO 13485, QSR, and international standards.

• Excellent written and verbal communication skills for regulatory documentation and agency interactions.

• Ability to manage multiple projects in a fast-paced environment.

What we offer:

As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

· Full support and career-development resources to help you reach your potential

· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Apply now and let's make work better!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Temporary

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing

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