BioTalent
This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$100,000.00/yr - $120,000.00/yr Direct message the job poster from BioTalent Sr. Recruitment Consultant - Medical Device | QA/RA | Clinical | SF Bay Area
Sr. Regulatory Affairs Specialist – Medical Device - Onsite Required Compensation:
$100,000–$120,000 base + bonus A Class I medical device manufacturer is seeking a
Senior Regulatory Affairs Specialist
to support U.S. and international regulatory submissions and ensure ongoing compliance with global regulations. This is a high-impact role focused on supporting wireless, cybersecurity-enabled, and sterile products. Key Responsibilities: Prepare, review, and submit regulatory documents including technical files, amendments, supplements, and annual reports for global markets. Maintain regulatory databases and product licenses across various jurisdictions. Interpret and apply FDA (21 CFR Part 820), ISO, and other international medical device regulations. Develop and implement internal regulatory policies and SOPs to support compliance. Collaborate cross-functionally to manage documentation and support audits or regulatory requests. Track submission timelines and ensure timely responses to regulatory agencies. Required Qualifications: Bachelor’s degree in engineering, life sciences, or a related field. 8–10 years of regulatory affairs experience, including at least 2 years in medical devices. Must have hands-on experience with
international product registrations
and regulatory strategies. Deep knowledge in one or more of the following areas is
required : Wireless technology Cybersecurity regulations Strong written and verbal communication skills. Ability to manage multiple projects and work independently in a fast-paced environment. This role is best suited for a senior-level regulatory professional who thrives in a dynamic, cross-functional team and has a proven track record navigating complex global regulatory landscapes. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal, Quality Assurance, and Management Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at BioTalent by 2x Get notified about new Regulatory Specialist jobs in
Union City, CA . Menlo Park, CA $118,000.00-$172,000.00 2 weeks ago Sunnyvale, CA $118,000.00-$172,000.00 2 weeks ago Union City, CA $100,000.00-$120,000.00 2 weeks ago Medical Devices Regulatory Affairs Strategy Specialist
Regulatory Compliance Specialist / Req 822408492
Alameda, CA $83,241.60-$124,862.40 1 week ago Regulatory Affairs Specialist - (NMPA/CFDA)
Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Senior Regulatory Affairs Specialist - Vascular (on-site)
Regulatory Affairs Assoc II CMC - Small Molecules
San Francisco Bay Area $109,650.00-$141,900.00 11 hours ago Milpitas, CA $115,000.00-$150,000.00 1 week ago Union City, CA $130,000.00-$155,000.00 3 days ago Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Health Transactional/Regulatory Associate
Sunnyvale, CA $80,000.00-$140,000.00 5 days ago Sr Regulatory Affairs Specialist (Remote) - Shockwave
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
Santa Clara, CA $89,000.00-$165,600.00 6 days ago Regulatory Operations Specialist - Temporary
South San Francisco, CA $31.00-$42.00 4 hours ago Regulatory Affairs Compliance Specialist - Pleasanton, CA
Pleasanton, CA $115,000.00-$125,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
$100,000.00/yr - $120,000.00/yr Direct message the job poster from BioTalent Sr. Recruitment Consultant - Medical Device | QA/RA | Clinical | SF Bay Area
Sr. Regulatory Affairs Specialist – Medical Device - Onsite Required Compensation:
$100,000–$120,000 base + bonus A Class I medical device manufacturer is seeking a
Senior Regulatory Affairs Specialist
to support U.S. and international regulatory submissions and ensure ongoing compliance with global regulations. This is a high-impact role focused on supporting wireless, cybersecurity-enabled, and sterile products. Key Responsibilities: Prepare, review, and submit regulatory documents including technical files, amendments, supplements, and annual reports for global markets. Maintain regulatory databases and product licenses across various jurisdictions. Interpret and apply FDA (21 CFR Part 820), ISO, and other international medical device regulations. Develop and implement internal regulatory policies and SOPs to support compliance. Collaborate cross-functionally to manage documentation and support audits or regulatory requests. Track submission timelines and ensure timely responses to regulatory agencies. Required Qualifications: Bachelor’s degree in engineering, life sciences, or a related field. 8–10 years of regulatory affairs experience, including at least 2 years in medical devices. Must have hands-on experience with
international product registrations
and regulatory strategies. Deep knowledge in one or more of the following areas is
required : Wireless technology Cybersecurity regulations Strong written and verbal communication skills. Ability to manage multiple projects and work independently in a fast-paced environment. This role is best suited for a senior-level regulatory professional who thrives in a dynamic, cross-functional team and has a proven track record navigating complex global regulatory landscapes. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal, Quality Assurance, and Management Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at BioTalent by 2x Get notified about new Regulatory Specialist jobs in
Union City, CA . Menlo Park, CA $118,000.00-$172,000.00 2 weeks ago Sunnyvale, CA $118,000.00-$172,000.00 2 weeks ago Union City, CA $100,000.00-$120,000.00 2 weeks ago Medical Devices Regulatory Affairs Strategy Specialist
Regulatory Compliance Specialist / Req 822408492
Alameda, CA $83,241.60-$124,862.40 1 week ago Regulatory Affairs Specialist - (NMPA/CFDA)
Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Senior Regulatory Affairs Specialist - Vascular (on-site)
Regulatory Affairs Assoc II CMC - Small Molecules
San Francisco Bay Area $109,650.00-$141,900.00 11 hours ago Milpitas, CA $115,000.00-$150,000.00 1 week ago Union City, CA $130,000.00-$155,000.00 3 days ago Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Health Transactional/Regulatory Associate
Sunnyvale, CA $80,000.00-$140,000.00 5 days ago Sr Regulatory Affairs Specialist (Remote) - Shockwave
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
Santa Clara, CA $89,000.00-$165,600.00 6 days ago Regulatory Operations Specialist - Temporary
South San Francisco, CA $31.00-$42.00 4 hours ago Regulatory Affairs Compliance Specialist - Pleasanton, CA
Pleasanton, CA $115,000.00-$125,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr