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Regulatory Affairs Specialist
Posted: 08/25/2025
Employment Type:
Direct Hire
Job Number: 30842
Job Location:
Industry: MFG â Manufacturing
Job Description
Position Title: Regulatory Affairs Specialist
Position Description: Protingent Staffing has an exciting direct hire Regulatory Affairs Specialist opportunity.
Job Responsibilities:
Job Qualifications:
Job Details:
About Protingent: Protingent is an Award-Winning provider of top-tier Engineering and IT talent, trusted by companies at the forefront of innovation — from Software and Aerospace to AI, Clean Tech, Medical Devices, and Connected Technologies. We’re passionate about making a positive impact by connecting exceptional talent with meaningful opportunities and helping our clients build the future.
Position Description: Protingent Staffing has an exciting direct hire Regulatory Affairs Specialist opportunity.
Job Responsibilities:
- Compile, prepare, review, and assemble regulatory documents necessary for submissions in accordance with regulations and relevant guidelines.
- Gather and assemble information/documentation for the company in the U.S. as well as internationally including but not limited to Device Master files, technical files, annual reports, amendments, supplements etc. and assist in delivery of regulatory documentation.
- Maintain regulatory database/network drive folders with regulatory information and submissions.
- May communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Review, recommend and present regulatory policies, methods, SOPs, protocols, reports for regulatory compliance and report on findings to assure adherence to FDA and global requirements.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Write or update standard operating procedures, work instructions, or policies.
- May Coordinate product recall or market withdrawal activities as necessary.
- Develop or track quality metrics.
- May participate in internal or external audits
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Participate in training courses and current trends to stay up to date with relevant laws, regulations and guidelines on medical devices developments.
- Develop rapport within and across the company regarding regulatory matters.
- Maintain and develop timelines for regulatory submissions and correspondence for company sponsored projects.
- Follow general instructions to complete projects, plan and organize workday to complete time sensitive assignments.
- Under the management direction, maintain the Device Manufacturing licenses as required and mandated by the state and/or other regulatory agencies.
- Assist regulatory management and subject matter experts in the coordination of briefing documents and responses to requests or questions from government authorities or other entities.
- Understand, follow and support internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards)
Job Qualifications:
- Experience and education – as outlined below, per job level.
- Working Knowledge of 21 CFR and FDA guidelines (GMPs) and international regulatory requirements.
- Excellent Computer Skills – MS Word, Excel, PowerPoint
- Ability to express oneself orally and in writing in the English language. Ability to communicate effectively with Team Members across the organization and other business contacts in a courteous and professional manner.
- Excellent interpretive and interpersonal skills, including time management skills.
- Strong attention to detail.
- Ability to work on multiple tasks to meet company requirements.
- Demonstrated ability to coordinate and work effectively with cross-functional teams.
Job Details:
- Job Type: Direct Hire
- Salary Range: $134K - $160K
- Location: Union City, CA.
About Protingent: Protingent is an Award-Winning provider of top-tier Engineering and IT talent, trusted by companies at the forefront of innovation — from Software and Aerospace to AI, Clean Tech, Medical Devices, and Connected Technologies. We’re passionate about making a positive impact by connecting exceptional talent with meaningful opportunities and helping our clients build the future.
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Ready to kickstart your career in Union City, California? Nestled in the heart of the Bay Area, this vibrant city offers a perfect blend of urban amenities and natural beauty for job seekers looking to thrive. With proximity to iconic landmarks like Coyote Hills Regional Park and the Garin Regional Park, as well as a diverse culinary scene featuring delicious fusion dishes, Union City is an ideal place to work and play. Explore career opportunities amid the thriving arts scene, including the Rhythmix Cultural Works and the Union City Art Gallery. Join us in this dynamic region filled with charm and endless growth opportunities – your dream job awaits!