Regulatory Engineer Jobs

Must have strong classification and appraisement skills, having 2 or more years’ experience in this area.

Completion of University degree or equivalent experience.

Ability to multitask; very organized, high degree of communication and analytical skills.

Candidate must have excellent writing skills.

5+ years of comparable Customs Operations experience.

Excellent working knowledge of Title 19 of the Code of Federal Regulations and United States Code.

A combination of post-secondary education and/or job-related experience may substitute for the minimum qualifications on a year-for-year basis

MSHA Mine Safety Class and Certification or ability to obtain certification within two months

Perform work with a greater purpose

Opportunities for growth and development within Maricopa County

Exceptional work-life balance, with hybrid and alternative work schedule options

Low-cost, high-value healthcare for you and your qualifying dependents

Manage all aspects of regulatory affairs, including preparing and submitting regulatory submissions, reviewing labeling and advertising materials, and maintaining regulatory documentation.

3+ years of experience in regulatory affairs and quality engineering in the medical device industry.

Experience managing product submissions and interfacing with regulatory bodies.

Excellent problem-solving and analytical skills, with a keen attention to detail.

Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.

Lead quality control efforts, conducting product testing, analyzing data, and identifying areas for improvement in product design and manufacturing processes.

Strong project management skills, with the ability to manage multiple projects simultaneously.

Develop and implement CMC regulatory strategies for new product development and product lifecycle management.

Knowledge of regulatory requirements and guidelines, including FDA and EMA regulations

Manage and oversee the preparation and submission of regulatory documents, including INDs, BLAs, and amendments.

Provide guidance and support to cross-functional teams on regulatory CMC requirements and strategies.

Stay up to date with changes in regulatory requirements and industry trends that may impact product development and regulatory submissions.

Manage Regulatory Information for New Product Development (NPD)

Support retail teams for registration in international markets

Execute and assist in registration process by submitting formulations for third-party review

Review documentation for accuracy and compliance with US and international markets

Highly motivated with the ability to thrive and multi-task in a fast-paced and demanding environment, passionate about cosmetics.

Request and submit samples for testing

Experience with FTC advertising requirements, claims substantiation, investigations, and regulations.

Knowledge of 510(k) assessments, recall issues, import/export matters, and FDA inspections.

Must have at least one year of Paralegal experience

Preferred qualifications for this Paralegal role include:

What you bring to the table as an experienced Paralegal:

At least one year of Paralegal experience is required.

Strong project management and organizational skills

Engage in personal and professional development projects to maintain continual growth in professional skills and knowledge essential for regulatory requirements

Demonstrates highly effective communications skills with the ability to influence business units

Ability to independently work, be counted upon, manage priorities, and remain flexible in a changing environment while meeting project timelines

Excellent interpersonal skills along with strong written and verbal communication skills across all levels of the organization

5+ years’ cybersecurity experience with at least 3+ years in an operationally focused security practitioner role

Preferred Education: Associates degree in graphic design or related field, or equivalent experience

Effectively manages projects of moderate scope including planning, control, and delivery against timeline and budget metrics

Documents progress against the project plan throughout the project. Formulates status reports and presents to the team and immediate manager.

Preferred Work Experience (years): 1-2 years of experience

Possess strong written and oral communication skills

Intermediate presentation skills to cross functional audience.

Review and interpret new and proposed environmental laws and regulations, and provide guidance to management

Coordinate and manage contractors for surveys. Review and maintain reports and other relevant records from such surveys

Maintain recordkeeping and compliance requirements

Knowledge of the National Environmental Policy Act (NEPA)

3+ years of experience in environmental sciences

Demonstrated experience in National Environmental Policy Act documentation (NEPA)

Educates organization leadership and medical staff on changes to accreditation /regulatory requirements.

Provides regulatory guidance and support to medical staff and operations leaders /councils pursuing specific TJC certifications.

Actively performs audits to evaluate compliance on regulatory requirements. Directs development and implementation of action plans to address non-compliance.

Mentors and provides guidance for the development of educational opportunities for the organization relative to standards and accreditation regulations.

Five (5) years of clinical or related experience, including experience in healthcare quality/performance improvement projects

Responsible for completion of components of The Joint Commission application for submission of required data and documentation.

Training/Experience Requirements:At least 10 years drug OR device regulatory experience.

Responsibilities include:Develop regulatory strategies for global submissions

Manage FDA and other global health authority face-face communications and via all other communication channels

Some experience in quality assurance roles or auditing preferred

Both drug and device experience a plus

Mix of large sponsor company and small startup experience a plus

Over five years of experience at a nationally recognized law firm and/or in-house at a financial institution

Excellent written and oral communication skills

Skilled to communicate organizational values, address conflicts and deliver difficult messages

Skills that will help you in the role:

Working with stakeholders across the group to develop integrated global regulatory strategies

Monitoring legal and regulatory developments in multiple jurisdictions and anticipating and assessing impact on Barclays’ core businesses

4-9 years of work experience in financial services

3-5 years of regulatory reporting experience including but not limited to SEC, CFTC/NFA, Federal Reserve/Treasury, SFC, MAS and KFB filings

Prepare filing responses for various regulators

Work with the technology team to further develop a process for governing the global inventory of filings

Perform research/benchmark vendors to determine how others have automated their processes

Class action lawsuit analysis for anti-trust cases