Senior Regulatory Affairs Specialists are pivotal in ensuring the successful clearance and compliance of products in the global healthcare scene. Their role involves compiling, reviewing, and submitting regulatory documents to government bodies. They ensure that their companies comply with all of the regulations and laws pertaining to their business. Browse through our extensive list of senior regulatory affairs specialist positions in top companies across the country.
Senior Regulatory Affairs Specialists analyze and coordinate the collection of scientific data to be shown in product labeling, investigator brochures, and new drug applications. They also revise product labeling and documentation to ensure compliance with regulatory standards and review the results of laboratory, animal, and human clinical testing trials to determine if they satisfy regulatory requirements.
To become a successful Senior Regulatory Affairs Specialist, strong analytical and communication skills, a keen eye for detail, and a strong background in regulations are required. Mastery of regulatory requirements and dedication to continued learning is crucial for success in this role.
Senior/Principal Regulatory Affairs Specialist
$110K - $130K *
Transform regulatory strategies to ensure compliance for innovative medical devices while collaborating with cross-functional teams on product development and clinical studies. Drive timely submission...
Reposted 2 days ago
Senior Regulatory Affairs Associate - Generalist
$100K - $120K *
Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...
Reposted 2 weeks ago
Senior Regulatory Affairs Specialist
$110K - $130K *
Engage in international regulatory affairs, driving submissions, registrations, and lifecycle management for medical devices in the UK, Japan, and Latin America. Collaborate with regulatory bodies and...
5 days ago
Senior Regulatory Affairs Specialist
$95K - $115K *
Deliver compliance leadership by coordinating regulatory deliverables for product portfolios. Monitor regulations, manage change controls, mentor team members, and ensure high-quality execution of com...
Reposted 1 week ago
$85K - $100K *
Elevate regulatory standards by coordinating global submissions for medical devices, ensuring compliance with U.S. and international guidelines while supporting cross-functional collaboration and stra...
1 week ago
Senior Regulatory Affairs Specialist (Columbia, MD)
$101K - $152K *
Empower effective regulatory strategy development for HCT/P and combination products. Lead submissions and audits while ensuring compliance with FDA standards. Collaborate with teams to foster excelle...
Reposted 5 days ago
Senior Regulatory Affairs Labeling Specialist
$121K - $143K *
Lead regulatory labeling activities to ensure compliance and clarity in product documentation. Collaborate with cross-functional teams while managing external partners, contributing to label design an...
1 week ago
Regulatory Affairs Specialist II
$90K - $125K *
Elevate regulatory processes by coordinating submissions for global approvals, ensuring compliance and facilitating access to vital healthcare technologies through meticulous documentation and project...
Reposted 5 days ago
Senior Regulatory Affairs Associate
$80K - $95K *
Optimize global regulatory compliance by managing submissions, audits, and documentation. Collaborate on EU MDR projects and ensure alignment with standards while supporting product registrations and...
3 days ago
Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)
$91K - $137K *
Join a team that's dedicated to ensuring regulatory compliance for medical devices. Lead initiatives for domestic and international registrations while collaborating with marketing and development tea...
1 week ago
Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)
$91K - $137K *
Transform medical device regulatory processes by collaborating across teams to ensure compliance and facilitate submissions for both domestic and international markets, while safeguarding product qual...
1 week ago
Senior Regulatory Affairs Specialist (Hybrid - Acton, MA)
$91K - $137K *
Grow your career with a dynamic team, driving regulatory excellence across medical device markets, ensuring compliance, and supporting product development initiatives globally...
1 week ago
Senior Regulatory Affairs Specialist
$101K - $152K *
Execute regulatory strategies for global product approvals, guiding teams through the lifecycle and managing submissions. Foster agency relationships, maintain compliance, and lead audits while mentor...
Reposted 2 weeks ago
$80K - $95K *
Shape the future of medical devices by securing 510k and NDA approvals through strategic regulatory compliance. Collaborate cross-departmentally to streamline submissions, maintain documentation, and...
2 weeks ago
Senior Regulatory Affairs Specialist
$83K - $103K *
Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...
Reposted 2 days ago
Senior Regulatory Affairs Specialist
$110K - $130K *
Shape the future of regulatory affairs by driving compliance and strategic planning for global product registrations. Collaborate cross-functionally to enhance processes and ensure successful submissi...
1 week ago
Senior Regulatory Affairs Specialist
$100K - $120K *
Lead the charge in ensuring compliance with global regulatory standards, facilitating efficient processes for product registration. Collaborate cross-functionally while managing submissions and develo...
1 week ago
Regulatory Affairs Specialist I
$77K - $98K *
Join a team that's dedicated to securing regulatory approvals for innovative medical technologies, ensuring access to life-saving products worldwide while managing multiple submissions and collaborati...
Reposted 2 days ago
Regulatory Affairs Specialist II
$80K - $100K *
Help us shape the future of regulatory compliance by supporting submissions, approvals, and post-launch activities. Engage with cross-functional teams to ensure adherence to guidelines while managing...
Reposted 2 weeks ago
Regulatory Affairs Specialist II
$75K - $142K *
Advance regulatory compliance for medical devices, coordinating submissions and strategies across international markets to ensure quality and efficiency in product development and partnerships...
3 weeks ago
Principal Regulatory Affairs Specialist
$110K - $130K *
Elevate your career by leading regulatory strategy for high-risk medical devices. Collaborate with teams to ensure compliance, prepare submissions, and maintain product registrations. Your expertise w...
2 weeks ago
Senior Specialist, Regulatory Affairs, Medical Devices
$95K - $115K *
Lead the charge in regulatory strategies for medical devices, guiding global submissions and compliance, while mentoring team members to deliver high-quality regulatory outcomes aligned with best prac...
Reposted 1 week ago
Regulatory Affairs Sr Specialist
$89K - $134K *
Accelerate regulatory excellence by guiding product compliance amid dynamic market demands. Collaborate cross-functionally to influence strategy, ensure adherence to regulations, and facilitate succes...
Reposted 3 days ago
Senior Regulatory Scientist - Audit & Compliance
$77K - $115K *
Unlock potential by managing regulatory compliance for biocides, overseeing audits and risk management. Collaborate with stakeholders to ensure adherence to EPA regulations and enhance operational eff...
Reposted 1 week ago
$95K - $115K *
Unlock potential by leading comprehensive regulatory strategies for complex devices. Act as a key expert in multiple scientific disciplines, managing priorities while ensuring compliance with global r...
2 weeks ago
What does a Senior Regulatory Affairs Specialist do?
Senior Regulatory Affairs Specialists ensure product compliance with regulatory agencies. They compile and submit documentation required for clearance, perform internal audits, and ensure the business adheres to relevant laws and regulations.
What skills are needed for a Senior Regulatory Affairs Specialist job?
Key skills include knowledge of regulatory requirements, strong analytical and communication skills, attention to detail, and a commitment to continuous learning.
Where can I find Senior Regulatory Affairs Specialist jobs?
You can find top Senior Regulatory Affairs Specialist jobs that pay $100k and up on Ladders.
How can I progress in a Senior Regulatory Affairs Specialist career?
Progression can be achieved through continuous learning, keeping abreast of changes in regulations, obtaining relevant certifications, and gaining experience in various regulatory affairs roles.