Regulatory Affairs Specialist

Regulatory Affairs Specialist Resume Keywords and Skills (Hard Skills)

Here are the keywords and skills that appear most frequently on recent Regulatory Affairs Specialist job postings. In other words, these are the most sought after skills by recruiters and hiring managers. Go to Sample Templates ↓ below to see how to include them on your resume.

Remember that every job is different. Instead of including all keywords on your resume, identify those that are most relevant to the job you're applying to. Use the free Targeted Resume tool to help with this.

Choose a category
  • Regulatory Affairs
  • Regulatory Submissions
  • U.S. Food and Drug Administration (FDA)
  • Regulatory Requirements
  • Medical Devices
  • Quality System
  • Good Manufacturing Practice (GMP)
  • ISO 13485
  • Standard Operating Procedure (SOP)
  • Corrective and Preventive Action (CAPA)
  • Design Control
  • Biotechnology
  • Validation
  • Regulatory Documentation
  • Clinical Trials
  • CE marking
  • Regulatory Compliance
  • Electronic Common Technical Document (eCTD)
  • Global Regulatory Compliance
  • Good Clinical Practice (GCP)
  •   Show full list

Resume Skills: Regulatory Knowledge

  • FDA and international regulations
  • GMP (Good Manufacturing practices)
  • GDP (Good Documentation practices)
  • GCP (Good Clinical practices)
  • Medical Device Directive (MDD)
  • FDA
  • EU-MDR
  • ICH
  • ISO 13485
  • ISO 9001
  • FDA Guidelines
  • EU Guidelines
  • Pharmaceuticals Legislation
  • Medical Device Directives (MDD)
  • ICH Guidelines
  • EU and U.S. FDA Regulations
  • Medical Device Single Audit Program (MDSAP)
  • Quality Management Systems (ISO 13485)
  • Good Clinical Practices (GCP)
  • FDA Regulations
  • CE Marking
  • MDR and IVDR
  • EMA
  • ICH and GxP guidelines
  • ISO 13485 and IEC 62304

Resume Skills: Software

  • Microsoft Office Suite
  • SAP
  • TrackWise
  • MasterControl
  • Regulatory Information Management Systems (RIMS)
  • Veeva Vault RIM
  • Documentum
  • Project Management Software (Asana, Trello)
  • Document Control Systems (MasterControl)
  • Regulatory One
  • ennov Regulatory
  • LORENZ DocuBridge
  • RegTrak
  • Parexel Infosario
  • Ennov

Resume Skills: Technical

  • MS Office
  • SAP
  • Documentum
  • Adobe Acrobat
  • SharePoint
  • TrackWise
  • AutoCAD
  • Quality Assurance
  • Quality Control
  • Regulatory Strategy
  • MS Office Proficient
  • Agile and Waterfall methodologies
  • SQL
  • Regulatory Information Management Systems (RIMs)
  • Electronic Document Management Systems (EDMS)
  • Statistical Analysis Software (SAS)
  • SOP Development
  • Clinical Trials
  • Risk Assessment (ISO 14971)

Resume Skills: Certifications

  • Certified Quality Process Analyst (CQPA)
  • Certified Regulatory Affairs Professional (CRAP)

Resume Skills: Quality Assurance Tools

  • SPC (Statistical Process Control)
  • Risk Management
  • CAPA (Corrective and Preventive Actions)
  • Verification & Validation

Resume Skills: Compiling Documents

  • Technical File
  • Design Dossier
  • PMAs
  • 510(k)s
  • MDDs

Resume Skills: Quality Assurance

  • Quality Management System (QMS)
  • Good Clinical Practices (GCP)
  • Corrective and Preventive Actions (CAPA)
  • Lean Six Sigma methodology

Resume Skills: Languages

  • English
  • French
  • Spanish
  • Spanish (Professional Proficiency)
  • German
  • French (Professional Proficiency)

Resume Skills: Regulatory Affairs

  • FDA Submissions
  • EMA Procedures
  • Regulatory Inspections
  • Product Labeling
  • Quality Auditing
  • Post-Launch Surveillance

Resume Skills: Quality Control & Assurance

  • Quality Assurance Monitoring
  • Deviation Management
  • Corrective and Preventive Action (CAPA)
  • Good Manufacturing Practice (GMP)
  • Standard Operating Procedures (SOPs)

Resume Skills: Research Methods

  • Epidemiology
  • Pharmacoeconomics
  • Biostatistics
  • Health Outcomes Research
  • Systematic Reviews and Meta-Analyses
  • Pharmacoepidemiology
  Does your resume contain all the right skills? Paste in your resume in the AI Resume Scan ↓ section below and get an instant score.

Sample Regulatory Affairs Specialist Resume: How To Include These Skills

Add keywords directly into your resume's work experiences, education or Skills section, like we've shown in the examples below. Use the examples below as inspiration.

Choose a template
Your Name
Regulatory Affairs Associate
City, Country  •  (123) 456-789  •  [email protected]  •
Medtronic February 2021 - Present
Regulatory Affairs Associate
Prepared and submitted efficient eCTD applications, leading a significant decrease in approval time by 15%.
Efficiently interpreted and applied FDA regulatory requirements to company operations, reducing regulatory associated risks by 20%.
Partnered with cross-functional teams ensuring products meet applicable regulatory standards and requirements, alongside obtaining CE marking for three novel products.
Executed quality audits, propelling the implementation of pertinent corrective actions and regulatory compliance.
Resume Worded June 2018 - January 2021
Regulatory Affairs Coordinator
Maintained up-to-date knowledge of Global Regulatory Compliance contributing to the reduction of non-compliance instances by 30%.
Created easy-to-understand training materials on regulatory affairs and SOPs, increasing team awareness by 40%.
Participated in pre-submission and development stages of biotechnology products, reducing time to market by 20%. July 2016 - May 2018
Product Quality Analyst
Improved complaint handling efficiency by implementing enhanced techniques, reducing complaint backlog by 25%.
Assisted with monitoring of post-market product performances, thereby optimizing patient safety by 15%.
Resume Worded University June 2018
Master of Science - Regulatory Affairs for Drugs, Biologics, and Medical Devices
Recipient of Regulatory Affairs Academic Excellence Award
Resume Worded Academic Center May 2016
Bachelor of Science - Biomedical Engineering
Majored in Biomaterials & Medical Devices
Activities: Member, Biomedical Engineering Society (BMES)
Regulatory Knowledge: FDA and international regulations, GMP (Good Manufacturing practices), GDP (Good Documentation practices), GCP (Good Clinical practices), Medical Device Directive (MDD)
Technical Skills: MS Office, SAP, Documentum, Adobe Acrobat, SharePoint, TrackWise, AutoCAD
Certifications: Certified Quality Process Analyst (CQPA), Certified Regulatory Affairs Professional (CRAP)
Quality Assurance Tools: SPC (Statistical Process Control), Risk Management, CAPA (Corrective and Preventive Actions), Verification & Validation
Certifications: Certified Associate in Regulatory Affairs (CARA), Quality Management Systems (ISO 13485) certification
Leadership & Volunteering: Volunteer, Doctors Without Borders, Spearheaded a volunteer medical device donation program
Projects: Conducted a comparative study on Regulatory Concerns in Medical Devices between EU, US and Canada
Professional Development: Attended Annual Conference of Regulatory Affairs Professionals Society (RAPS) & Regulatory Convergence, 2019
Your Name
Regulatory Affairs Consultant
City, Country  •  (123) 456-789  •  [email protected]  •
EXPERIENCE March 2021 - Present
Regulatory Affairs Consultant
Guided clients through complex regulatory landscapes facilitating the approval of five medical devices.
Worked with clients to ensure regulatory documentation is in line with industry standards, instrumental in reducing post-submission questions by 20%.
Provided expertise on regulatory affairs during Clinical Trials, enhancing trial success rates by 15%.
Assisted clients in achieving ISO 13485 compliance, enabling the broadening of their market reach.
Developed effective strategies to ensure adherence to Good Manufacturing Practice (GMP), improving manufacturing efficiencies by 25%.
Resume Worded July 2019 - February 2021
Regulatory Affairs Assistant
Conducted thorough market analysis regarding regulatory procedures, instrumental in the development of market entry strategies.
Supported in preparation of regulatory submissions in compliance with eCTD guidelines, accelerating approval times.
Implemented proper Design Control methodologies in product development cycles, improved product quality standards resulting in 15% fewer recalls.
Abbott labs June 2017 - June 2019
Junior Quality Analyst
Executed audit activities and compliance checks, identified gaps in processes and effective implementation of CAPA, reduced non-conformities by 10%.
Resume Worded University May 2017
Master of Science (MSc) in Regulatory Science
Top 5% of class, Graduated Cum Laude
Resume Worded Academic Center April 2019
Certified Regulatory Affairs Professional (CRAP)
Part-time Certification accomplished during Regulatory Affairs Assistant role at Resume Worded
Regulatory Software: RegTrak, Parexel Infosario, Ennov, Veeva Vault RIM
Regulatory Guidelines: FDA, EMA, ICH and GxP guidelines, MDR and IVDR, ISO 13485 and IEC 62304
Technical Skills: MS Office Proficient, Agile and Waterfall methodologies, SQL
Languages: English (Native), French (Conversational), German (Basic)
Certifications: Good Manufacturing Practice (GMP) Certification, Six Sigma Green Belt Certified
Leadership & Volunteering: Volunteer, United Way, Organized annual fundraisers raising over $20,000 annually
Awards: Recipient of Resume Worded Performance Excellence Award in 2020

Compare Your Resume To These Regulatory Affairs Specialist Skills (ATS Scan)

Paste your resume below and our AI will identify which keywords are missing from your resume from the list above (and what you need to include). Including the right keywords will help you get past Applicant Tracking Systems (i.e. resume screeners) which may scan your resume for keywords to see if you're a match for the job.

How do I add skills to a Regulatory Affairs Specialist resume?

Review the job posting closely.

Go through the Regulatory Affairs Specialist posting you're applying to, and identify hard skills the company is looking for. For example, skills like Regulatory Affairs, Regulatory Submissions and Medical Devices are possible skills. These are skills you should try to include on your resume.

Add industry skills like Good Manufacturing Practice (GMP) and Regulatory Requirements.

Add other common skills from your industry - such as Quality System, ISO 13485 and U.S. Food and Drug Administration (FDA) - into your resume if they're relevant.

Add skills into your work experience.

Incorporate skills - like Standard Operating Procedure (SOP), Global Regulatory Compliance and Regulatory Compliance - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

Show how you have strong attention to detail.

A good Regulatory Affairs Specialist has strong attention to detail, so try to include examples of where you handled complex projects or processes.

Use the exact job title.

Try to add the exact job title, Regulatory Affairs Specialist, somewhere into your resume to get past resume screeners. See the infographic for how to do this.

Word Cloud for Regulatory Affairs Specialist Skills & Keywords

The following word cloud highlights the most popular keywords that appear on Regulatory Affairs Specialist job descriptions. The bigger the word, the more frequently it shows up on employer's job postings. If you have experience with these keywords, include them on your resume.

Top Regulatory Affairs Specialist Skills and Keywords to Include On Your Resume

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Regulatory Affairs Specialist Resume Templates

Here are examples of proven resumes in related jobs and industries, approved by experienced hiring managers. Use them as inspiration when you're writing your own resume. You can even download and edit the resume template in Google Docs.

Resume Example
Regulatory Affairs Specialist

Resume Example
Regulatory Affairs Manager

Resume Example
Regulatory Affairs Associate (Entry Level)

Resume Example

Resume Example
Highlights (Free)

Resume Example
Modern Two-Column

Browse Skills from Similar Jobs

Frequently Asked Questions

What skills do hiring managers want to see on a Regulatory Affairs Specialist resume?

Some popular Regulatory Affairs Specialist hard skills are Regulatory Affairs, Regulatory Submissions, U.S. Food and Drug Administration (FDA), Regulatory Requirements, Medical Devices, Quality System, Good Manufacturing Practice (GMP) and ISO 13485.

Depending on the job you apply to, skills like Design Control, Regulatory Compliance, Global Regulatory Compliance, CE marking and Standard Operating Procedure (SOP) can also be good to include on your resume.

Target your Resume to a Job Description

While the keywords above are a good indication of what skills you need on your resume, you should try to find additional keywords that are specific to the job. To do this, use the free Targeted Resume tool. It analyzes the job you are applying to and finds the most important keywords you need on your resume.

It is personalized to your resume, and is the best way to ensure your resume will pass the automated resume filters.

Start targeting your resume

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