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.
$85K - $133K *
Join our team to ensure compliance and enhance patient safety in the medical device sector. Collaborate with cross-functional teams to manage adverse event reporting and promote continuous improvement...
Reposted 2 days ago
$85K - $133K *
Drive your career with a vital role ensuring compliance and patient safety in the medical device industry. Collaborate with cross-functional teams to investigate adverse events and support regulatory...
Reposted 2 days ago
Quality Assurance Specialist I *PC 602
$80K - $94K *
Transform quality assurance processes within our manufacturing operations while ensuring compliance with cGMP standards and internal procedures. Provide on-the-floor support, conduct reviews, and coll...
2 weeks ago
Senior Director Regulatory Compliance, Abiomed
$178K - $307K *
Lead the charge in regulatory compliance across global MedTech operations, ensuring oversight, risk mitigation, and audit management. Collaborate cross-functionally to develop robust strategies that a...
4 days ago
$100K - $130K *
Launch impactful engineering projects by leading cost improvement initiatives and design changes in a regulated medical device environment. Collaborate with cross-functional teams to ensure compliance...
4 weeks ago
$100K - $130K *
Join a team that's leading innovative Cost Improvement Projects in medical devices. You'll manage engineering efforts, ensuring compliance while driving change and collaboration across cross-functiona...
4 weeks ago
$85K - $110K *
Transform your career by leading commissioning, qualification, and validation activities for a state-of-the-art biologics facility, ensuring compliance and operational excellence in a fast-paced envir...
5 days ago
Associate Electrical Engineer, Capital Equipment, R&D - MedTech
$76K - $121K *
Advance innovative surgical technologies by developing cutting-edge capital equipment. Collaborate with experienced engineers to ideate, prototype, and test solutions that enhance patient care and red...
Reposted 2 days ago
Principal Computer System Validation Specialist
$105K - $150K *
Lead the validation of GxP computerized systems, ensuring compliance with regulations. Collaborate with cross-functional teams to maintain validation deliverables and support audit readiness in a dyna...
1 week ago
$148K - $159K *
Unlock enterprise contracting success by delivering cradle-to-grave support, including analysis, negotiation, and management of contracts while ensuring compliance and efficiency in procurement proces...
5 days ago
Expert Consultant - Biocompatibility Expert - US
$100K - $130K *
Engage as a senior scientific leader in biocompatibility assessments for medical devices. Drive strategies and develop regulatory-ready evaluations while collaborating with clients and cross-functiona...
2 weeks ago
Expert Consultant - Biocompatibility Expert - US
$100K - $130K *
Drive biocompatibility assessments and strategies for medical device products. Collaborate across teams, ensuring regulatory readiness and safeguarding patient health through expert evaluations and do...
2 weeks ago
$132K - $150K *
Explore opportunities as a senior professional driving product lifecycle management, collaborating on design development and troubleshooting in the endovascular space. Contribute to innovation and use...
3 weeks ago
Sr Mgr Product Quality Integrator
$122K - $212K *
Lead the charge in ensuring end-to-end product quality for large molecules from development to commercialization. Collaborate with cross-functional teams to implement quality strategies, manage compli...
1 week ago
Sr Mgr Product Quality Integrator
$122K - $212K *
Advance quality assurance processes for biotherapeutics from development to commercialization. Lead cross-functional teams, ensuring compliance with regulatory standards and enhancing product quality...
1 week ago
Sr Mgr Product Quality Integrator
$122K - $212K *
Drive quality strategies for biotherapeutics from development to launch. Ensure compliance and lead cross-functional teams to meet regulatory standards for large molecules, managing resources and qual...
1 week ago
$90K - $120K *
Elevate your career by joining our Compliance Consulting practice to drive projects, implement methodologies, and enhance compliance practices for asset managers using market-leading OMS technology...
6 days ago
$89K - $102K *
Champion quality engineering processes by mentoring teams, designing automation frameworks, and enhancing testing methodologies to deliver high-quality products while collaborating with cross-function...
6 days ago
$89K - $102K *
Unlock quality excellence by driving initiatives and collaborating with cross-functional teams. Take on advanced responsibilities in test automation, mentoring, and enhancing product quality through s...
6 days ago
Senior Clinical Engineer – RO & GIP
$100K - $150K *
Advance clinical imaging solutions by evaluating and enhancing product efficacy, ensuring customer needs inform the innovation process, and collaborating across diverse teams to improve healthcare out...
4 weeks ago
$75K - $95K *
Accelerate your impact in quality assurance by overseeing CMC operations, managing batch releases, and ensuring compliance. Collaborate with teams to uphold regulatory standards while enhancing your e...
4 weeks ago
Compliance Specialist/Senior Compliance Specialist
$78K - $101K *
Lead the charge in developing and implementing compliance processes within Engineering and Operations. Ensure adherence to laws and regulations while enhancing operational efficiency through collabora...
Reposted 1 week ago
$74K - $92K *
Advance the quality control processes by conducting thorough testing, analyzing data trends, and ensuring compliance with industry regulations. Collaborate across departments while leading projects to...
1 week ago
Associate Director, Regulatory Operations
$141K - $194K *
Lead the charge in global regulatory strategy execution, optimizing processes and ensuring compliance with health authority requirements. Drive submission planning and tracking while leveraging Veeva...
1 week ago
Senior Associate Scientist - Analytical Development
$70K - $95K *
Advance analytical methods to support critical biological development projects. Collaborate with teams to optimize assays and ensure compliance with regulatory standards while maintaining timelines an...
3 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.