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 Regulatory Affairs Specialist
$95K - $115K *
Drive regulatory excellence by leading and supporting medical device compliance efforts. Utilize your expertise to facilitate product development and global market access while ensuring quality delive...
2 weeks 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 5 days ago
Senior Regulatory Affairs Specialist
$115K - $156K *
Unlock potential by guiding regulatory strategies for new and existing medical devices. Collaborate across teams to ensure compliance with global regulations while managing submissions and assessments...
3 weeks ago
Senior Regulatory Affairs Specialist
$101K - $131K *
Lead compliance and regulatory activities for medical devices, ensuring adherence to FDA and international standards while managing risk assessments and product recalls. Collaborate cross-functionally...
3 weeks ago
Senior Regulatory Affairs Specialist
$101K - $131K *
Drive compliance and regulatory strategy by evaluating product changes, managing post-market activities, and coordinating across departments to ensure adherence to global regulations, supporting safet...
3 weeks 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 today
Senior Regulatory Affairs Specialist
$120K - $145K *
Unlock potential by leading global regulatory submissions and strategic compliance initiatives, ensuring adherence to international standards while mentoring specialists and optimizing project timelin...
2 weeks ago
Lead Regulatory Affairs Specialist
$151K - $178K *
Drive regulatory excellence by leveraging your expertise in compliance and strategic assessments for medical device projects. Collaborate cross-functionally to ensure adherence to FDA and internationa...
3 weeks 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...
Yesterday
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...
Yesterday
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...
2 days ago
$88K - $130K *
Collaborate with cross-functional teams to integrate regulatory knowledge throughout the product lifecycle, ensuring compliance and effective project coordination for market authorizations in the medi...
Reposted 1 month 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...
Yesterday
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...
Yesterday
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 5 days ago
Sr. Regulatory Affairs Specialist
$95K - $115K *
Drive regulatory success by managing complex submissions globally, ensuring compliance with diverse requirements. Collaborate with cross-functional teams to guide product development and maintain up-t...
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...
6 days 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 6 days 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...
2 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...
1 week 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...
2 days ago
Associate Specialist, Regulatory Affairs - Hybrid
$71K - $113K *
Lead the charge in optimizing global regulatory affairs by supporting critical business operations and enhancing user experience through effective documentation, training, and change management, ensur...
Today
Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)
$95K - $159K *
Transform the regulatory landscape by leading product lifecycle strategies, ensuring compliance in global markets, and collaborating with multidisciplinary teams for medical device advancements...
Today
Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)
$95K - $159K *
Strategize regulatory affairs initiatives to guide product lifecycle management, ensuring compliance across U.S. and international markets while collaborating with cross-functional teams and regulator...
Today
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.