Shoolin Inc

Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…

EngineeringLife SciencesPharmaceuticalRecruitmentScienceStaffingTalent AcquisitionTechnology Solutionsshoolin-inc.com

Shoolin Inc

Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…

EngineeringLife SciencesPharmaceuticalRecruitmentScienceStaffingTalent AcquisitionTechnology Solutionsshoolin-inc.com

HQIselin, US

Team Size60

Open Jobs40

Total Funding-

Latest FundraiseUnknown

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Regulatory Specialist

On-SitePennsylvania, US

On-Site • Pennsylvania, US

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Job Title: Sr. Regulatory Specialist

Location: Philadelphia, PA (Onsite)

Mandatory Skill/Experience: 510(k)Submissions and Software as a Medical Device (SaMD) product

Job Summary:

Seeking a Senior Regulatory Specialist to support product development and regulatory activities for digital health and Software as a Medical Device (SaMD) product, including AI-based technologies. The role involves leading regulatory submissions, ensuring compliance with FDA and international regulations, and guiding cross-functional teams on regulatory strategies throughout the product lifecycle.

Required Qualifications:

Key Responsibilities:

Prepare, review, and submit 510(k) and Q-submission documents for SaMD and medical device products.
Provide regulatory guidance during design and development stages to ensure compliance with FDA and global standards.

Bachelor’s degree in science, engineering, or related discipline.

6–8 years of regulatory affairs experience in the medical device industry .

Hands-on experience with 510(k) submissions and SaMD regulatory filings .

Strong knowledge of FDA Quality System Regulations (21 CFR 11, 820) and ISO 13485 .

Familiarity with MDR 2017/745 , ISO 14971 , IEC 62304 , MDSAP , and related standards.

Experience with FDA Class I & II devices (Class III and OUS regulatory experience a plus).

Excellent communication, documentation, and cross-functional collaboration skills.

Review product labeling, design changes, and documentation for regulatory impact.

Support regulatory audits, authority interactions, and post-market compliance activities.

Maintain technical documentation including risk management reports , clinical evaluations , and regulatory filings .

Ensure compliance with product post-marketing and adverse event reporting requirements.