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Regulatory Affairs Specialist II Jobs in Iowa

Regulatory Affairs Intelligence Specialist
By Abbott Laboratories At , Plymouth $56,700 - $113,300 a year
Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
Experience in program management a plus
Experience with document management systems a plus
EDUCATION AND EXPERIENCE YOU’LL BRING
Performs other related duties and responsibilities, on occasion, as assigned
Strong verbal and written communication skills · Strong attention to detail and organizational skills
Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Des Plaines $71,300 - $142,700 a year
Interpret and apply regulatory requirements
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Principles and requirements of promotion, advertising and labeling
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Regulatory Affairs Specialist Jobs
By Philips At , Cambridge
Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
Proficient knowledge of domestic and international standards
Experience in supporting international registrations and/or clinical investigations.
Experience with Software Medical Devices strongly preferred.
Proficient computer skills in Microsoft Office Suite
Read more about our employee benefits.
Regulatory Affairs Specialist Cmc
By Viatris At , Remote $41,000 - $93,000 a year
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Regulatory Affairs Specialist Ii
By Thermo Fisher Scientific At , Fremont, 94555, Ca
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Perform other related duties and responsibilities, on occasion, as assigned.
Excellent communication skills and attention to detail.
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
Must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations. Excellent oral presentation skills.
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
Regulatory Affairs Specialist - Remote
By Corza Medical At , Remote
Superior Quality & Service. We deliver extraordinary experiences.
Development of tracking documents and follow-up to assure submissions are managed appropriately.
Minimum 2 years of experience in Regulatory Affairs in the medical device/drug industry.
Experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America.
Experience with medical device regulations (21 CFR, MDR, MDSAP, ISO 13485) and Biologics License Applications (21 CFR) preferred.
We do what is right.
Regulatory Affairs Specialist Jobs
By GC America Inc At , Remote
Consult with Product Management and Sales Administration on regulatory requirements for US and Canada
Work with product management to prepare, compile and maintain post market documentation
3 years of experience in regulatory affairs or quality assurance
Monitor regulatory environment in assigned markets(US, Canada) and communicate to global and domestic stakeholders
Prepare responses to regulatory authority requests by working with GCC regulatory affairs
Work with other GC Companies regulatory associates to support GCA sales and marketing needs associated with regulatory documentation
Specialist Data Maintenance Regulatory Affairs
By Viatris At , Remote $41,000 - $93,000 a year
Builds knowledge of electronic and paper publishing systems and tools and applies these tools to produce CMC change management outputs.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Quality Specialist - Rn (Regulatory Affairs)
By Stanford Health Care At , Palo Alto, 94304, Ca $64.52 - $85.49 an hour
Attends ongoing education as required for clinical database management.
Three (3) years of progressively responsible and directly related work experience
SHC Commitment to Providing an Exceptional Patient & Family Experience
You will do this by executing against our three experience pillars, from the patient and family’s perspective:
Conducts comprehensive quality and patient safety studies, assessments, and evaluations of specific clinical activities for effectiveness
Conducts work independently and escalates system issues as necessary.
Regulatory Affairs Sr Specialist (Remote)
By Zimmer Biomet At , Remote $98,700 - $122,500 a year

Requisition Number AMER27218 Employment Type Full-time Location Virtual Office - Indiana Job Summary Zimmer Biomet is a global medical technology leader. Our team members are ...

Are you looking for an exciting opportunity to use your regulatory expertise to make a difference? We are looking for a Regulatory Affairs Specialist II to join our team and help us ensure compliance with all applicable regulations. You will be responsible for developing and maintaining regulatory strategies, preparing regulatory submissions, and providing regulatory guidance to internal stakeholders. If you are an experienced regulatory professional with a passion for making a positive impact, this could be the perfect job for you!

A Regulatory Affairs Specialist II is responsible for ensuring that a company’s products comply with all applicable laws, regulations, and standards. This includes researching and interpreting regulations, preparing and submitting regulatory documents, and providing guidance on regulatory compliance.

What is Regulatory Affairs Specialist II Skills Required?

• Knowledge of applicable laws, regulations, and standards
• Excellent research and analytical skills
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team
• Attention to detail
• Project management skills

What is Regulatory Affairs Specialist II Qualifications?

• Bachelor’s degree in a related field
• At least two years of experience in regulatory affairs
• Certification in regulatory affairs (preferred)

What is Regulatory Affairs Specialist II Knowledge?

• Knowledge of applicable laws, regulations, and standards
• Knowledge of regulatory requirements for product development and approval
• Knowledge of Good Manufacturing Practices (GMPs)
• Knowledge of medical device regulations

What is Regulatory Affairs Specialist II Experience?

• Experience in regulatory affairs
• Experience in medical device or pharmaceutical industry
• Experience in preparing and submitting regulatory documents

What is Regulatory Affairs Specialist II Responsibilities?

• Research and interpret applicable laws, regulations, and standards
• Prepare and submit regulatory documents
• Provide guidance on regulatory compliance
• Monitor regulatory changes and update internal procedures