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.
Sr. Specialist Regulatory Affairs, Medical Devices
$90K - $120K *
Champion regulatory excellence by developing strategies and ensuring effective global registrations for medical devices, while mentoring team members and maintaining compliance with industry standards...
2 days ago
Senior Specialist, Regulatory Operations
$90K - $100K *
Manage site-level regulatory operations for clinical trials, ensuring compliance with U.S. regulations. Collaborate with cross-functional teams and provide guidance for regulatory submissions, fosteri...
Today
Regulatory Affairs Specialist II
$70K - $95K *
Join a dynamic team as you drive regulatory strategies and submissions for critical healthcare devices while collaborating across functions to ensure compliance and product excellence throughout the l...
3 weeks ago
Regulatory Affairs Specialist (Innovation)
$95K - $153K *
Support cross-functional teams by providing regulatory guidance for IVD product development, developing strategies, and conducting risk assessments to ensure compliance with FDA and EU regulations for...
4 weeks ago
Sr. Regulatory Affairs Specialist - Relocation Assistance Provided
$90K - $120K *
Contribute to regulatory compliance by managing 510(k) submissions and ensuring that products meet FDA and Canadian regulations. Collaborate across teams to maintain clear processes and uphold product...
2 weeks ago
Senior Manager, Regulatory Affairs
$161K - $202K *
Elevate global regulatory strategies for a diverse medical device portfolio, ensuring compliance and market access across regions. Lead cross-functional teams while influencing product lifecycle and e...
1 week ago
$120K - $150K *
Seeking a detail-oriented Regulatory Affairs Specialist to manage medical device compliance, documentation, and audits, ensuring adherence to FDA and ISO standards while collaborating across teams for...
4 days ago
Senior Specialist, Cell Therapy Trade Compliance (FTZ)
$89K - $134K *
Partner with us to ensure seamless FTZ operations and compliance for cell therapy logistics. You'll manage inventory integrity and align cross-functional teams to support critical patient material shi...
Reposted 1 week ago
Senior Regulatory Administration Specialist
$81K - $96K *
Drive excellence in board governance and regulatory filing for mutual funds. Oversee document management, provide insights on compliance, and coordinate cross-departmental efforts to ensure timely and...
4 days ago
Sr. Associate II, Regulatory Affairs Strategy
$102K - $133K *
Drive regulatory compliance for cutting-edge surgical medical devices, enhancing product access globally. Collaborate cross-functionally and provide guidance on regulatory strategies, ensuring alignme...
1 week ago
Sr. Associate II, Regulatory Affairs Strategy
$102K - $133K *
Join us to ensure regulatory compliance and drive excellence in our Surgical portfolio. You'll support regulatory strategy execution for medical devices, collaborate cross-functionally, and facilitate...
1 week ago
Regulatory Affairs Specialist 3 - Medical Device IVD
$105K - $132K *
Transform regulatory approaches by ensuring compliance for IVD products. Engage with global teams, devise strategies for submissions, mentor peers, and navigate evolving regulations to secure market a...
Reposted 2 days ago
$90K - $120K *
Unlock potential by leading regulatory submissions for medical devices, ensuring compliance with FDA and international standards. Collaborate across teams to expedite approvals and maintain regulatory...
3 days ago
Sr. Regulatory Compliance Specialist
$90K - $120K *
Lead the charge in regulatory compliance for diverse operations, ensuring alignment with laws and regulations. Manage corporate policies and conduct compliance audits while fostering a culture of awar...
Reposted today
Senior Quality Control Specialist
$75K - $95K *
Shape the future of quality control operations by leading technical initiatives, managing compliance, and driving continuous improvement in laboratory practices while collaborating with cross-function...
2 weeks ago
Senior Quality Control Specialist
$75K - $95K *
Engage as a technical leader in QC Operations to enhance quality systems and drive continuous improvements. Collaborate across departments, lead critical initiatives, and ensure compliance in a regula...
4 weeks ago
(Senior) Manager, Regulatory Affairs
$119K - $190K *
Lead the charge in regulatory submissions for EU and ex-U.S. markets, managing CTA preparation and execution, while collaborating across teams to ensure compliance and timely approvals in a fast-paced...
3 weeks ago
(Senior) Manager, Regulatory Affairs
$119K - $190K *
Join a team dedicated to transformative regulatory compliance, focusing on EU and ex-U.S. clinical trial applications. Lead critical submission strategies and foster collaboration across functions to...
3 weeks ago
Senior Clinical Research Specialist
$82K - $156K *
Unlock the potential of real-world data by guiding clinical research efforts. Collaborate cross-functionally to execute impactful studies and drive long-term strategies in Urology, enhancing the evide...
Reposted 3 weeks ago
Senior Clinical Research Specialist
$82K - $156K *
Join our dynamic Urology team as a Senior Clinical Research Specialist, guiding real-world evidence strategies to enhance clinical research activities, improve patient outcomes, and support innovative...
Reposted 3 weeks ago
Senior QA Specialist, Global Document Control Management
$90K - $108K *
Unlock potential by driving continuous improvement of our global GxP Document Management Program. Oversee document control processes, ensuring compliance with industry standards while collaborating ac...
3 weeks ago
Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist
$120K - $150K *
Elevate your career by leading global regulatory labeling strategies and initiatives. Oversee labeling governance, ensure compliance, and collaborate with cross-functional teams to support effective p...
1 week ago
Sr. Compliance Specialist - Audit , GMP
$80K - $110K *
Shape the future of compliance by leading audits, mentoring teams, and ensuring quality adherence to regulatory standards in a dynamic environment. Drive process improvements and maintain robust quali...
3 weeks ago
Sr. Compliance Specialist - Audit , GMP
$75K - $95K *
Transform compliance processes by leading audits, mentoring peers, and ensuring regulatory adherence. Drive quality improvements and enhance client relationships in a fast-paced, hybrid environment, b...
3 weeks ago
Regulatory Affairs Specialist Job Details | curium
$70K - $95K *
Accelerate progress at the forefront of regulatory compliance in healthcare, authoring submissions and ensuring adherence to FDA standards. Collaborate with cross-functional teams to manage product li...
1 week 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.