Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
View more jobs in San Diego, CA
View more jobs in California

Job Details

Principal Regulatory Affairs Specialist

San Diego, CA

Apply for this job

2 hit(s)  


Principle Regulatory Affairs SpecialistDirect placementTop 3 requirements: 510K submissions, CLIA submissions, IVD experienceNice to haves: U.S. and International submission experienceScope:The Principal Regulatory Affairs Specialist works as a high level independent contributor and is responsible for supporting the development and implementation of the overall objectives and long-range regulatory strategies that impact the introduction of new products, the market status of existing products and the development and maintenance of systems and processes that assure compliance with regulatory requirements. May serve as a mentor to help develop regulatory depth and knowledge within the regulatory department.Key Responsibilities:* Works with senior management by overseeing the activities required to insure that products manufactured and/or distributed by the company are in full compliance with U.S. and all applicable international regulatory requirements.* Maintains current knowledge of the developments and changes to applicable laws, regulations and industry standards.* Develops and implements regulatory strategies for new and modified products.* Provides regulatory guidance and direction as a core team member on manufacturing and development teams, throughout the product life-cycle, and identifies/coordinates cross functional deliverables for submissions.* Prepares submissions to obtain and maintain global regulatory approvals of products.* Reviews and approves device labeling and advertising & promotional materials to ensure continued compliance to global regulations; leads the development of regulatory strategies for new claims, indications and therapies.* Reviews and approves product and manufacturing changes for compliance with applicable regulations.* Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through verbal and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.* Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.* Provides regulatory representation on corporate-wide projects related to product development, design controls, design assurance, sustaining engineering and regulatory business systems.* Provides expertise and guidance in interpreting regulations and agency guidelines.* Provides support for acquisitions, including due diligence and post-acquisition assessment and education.* Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.* Provides support for internal and Regulatory Agency audits.* Builds Quality into all aspects of job performance by maintaining compliance to all quality requirements. About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffingu00ae Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please **** or email **** for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.nn 

Company info

Sign Up Now -

Similar Jobs:
Regulatory Affairs Specialist 2
Location : San Diego, CA
Grifols is a global healthcare company whose mission is to improve the health and well being of people.Our three divisions \u2013Bioscience, Diagnostic and Hospital\u2013develop, produce and market our innovative products and serv...
Legal/Compliance Specialist
Location : San Diego, CA
Overview Do you have an eye for detail? Great at working effectively across multiple business units? USE’s Risk Management Department is the perfect place for you! As a Legal/Compliance Specialist, you’ll have the chance to suppor...
Entry Level Compliance Coordinator
Location : San Diego, CA
Job Description WHO WE ARE: Premier Healthcare Services is a leading provider of skilled in-home nursing care for patients. We are currently looking for a passionate, empathetic, motivated and COMMITTED individual to fill our Comp...
I like the volume of jobs on EmploymentCrossing. The quality of jobs is also good. Plus, they get refreshed very often. Great work!
Roberto D - Seattle, WA
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ComplianceCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ComplianceCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ComplianceCrossing - All rights reserved. 168