regulatory affairs analyst

Arcera Life Sciences

<div>
 
 Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.
 
 
 
 
 
 This position is based in
 
 Cairo, Egypt
 
 and will report directly to the
 
 Regulatory Affairs Lead, GULF.
 
 The role will be responsible to support the RA Lead on all regulatory activities of assigned products within the Gulf region (UAE, Bahrain, Kuwait, Oman and Qatar). Ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs as well as support the Business through strong cross-functional collaboration.
 
 
 
 
 
 
 Your Responsibilities will be:
 
 
 
 
 
 <ul>
 <li>
 Support the Regulatory Affairs Lead on all the assigned Regulatory activities within the Gulf.
 </li>
 <li>
 Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.
 </li>
 <li>
 Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).
 </li>
 <li>
 Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
 </li>
 <li>
 Responsible of ordering and legalization of local CPP and other module 1 documents for local products.
 </li>
 <li>
 Perform regulatory due diligence on module 1 for all assigned products for the Gulf according to internal process/guidance according to EU/local Region regulatory requirements.
 </li>
 <li>
 Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.
 </li>
 <li>
 Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
 </li>
 <li>
 Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
 </li>
 <li>
 Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.
 </li>
 <li>
 Maintain the Regulatory databases: drug track and docubridge for local products.
 </li>
 <li>
 Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
 </li>
 <li>
 Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
 </li>
 <li>
 All trainings to be completed as per training plan.
 </li>
 </ul>
 
 
 
 
 
 Your Profile:
 
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmacy or a relevant field.
 </li>
 <li>
 0 &ndash; 3 years of experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.
 </li>
 <li>
 Fluent level in English and Arabic both in oral and written communication.
 </li>
 </ul>
 
 
 
 
 This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!
 
</div>

Regulatory Affairs Associate, GULF

Masimo

<div>Duties &amp; Responsibilities:
<ul><li>Process and maintain international filings/registrations in the assigned countries within the META Region.
</li><li>Generate and maintain product and process compliance checklists for the assigned countries.
</li><li>Maintain up-to-date knowledge on applicable regulatory requirements in the assigned countries.
</li><li>Provide counsel, training, and interpretation of applicable META Region regulatory requirements to company personnel.
</li><li>Liaise with in-country representatives on all matters relative to product and process regulatory requirements.
</li><li>Support operations, marketing, and sales with global market approvals for product shipment.
</li><li>Prepare and maintain other regulatory documentation, as needed in the assigned countries.
</li><li>Contribute to the implementation of regulatory best practices and efficient processes for regulatory information management.
</li><li>Generate/update quality system procedures owned by Regulatory Affairs, as required.
</li><li>Participate in relevant projects as regulatory subject matter expert.
</li><li>Perform other duties or special projects, as assigned.
</li><li>Collaborate with QA to drive Quality compliance in the region 
</li></ul>Minimum Qualifications:
<ul><li>Minimum 3 years of experience in international medical device Regulatory Affairs.
</li><li>Experience with the current Middle East regulations
</li><li>Excellent verbal and written communication skills in English.
</li><li>Experience working remotely with in-country representatives and with USA-based headquarters.
</li><li>Excellent prioritizing, organizational and interpersonal skills.
</li><li>Willingness to accommodate a flexible working schedule across time zones that may involve evening and weekend working hours depending on project requirements.
</li><li>Ability to work in a fast-paced environment, with multiple tasks/projects.
</li><li>A detailed-oriented individual with a &ldquo;can do&rdquo; attitude and ability to work in a team environment as well as individually with minimal supervision. 
</li></ul>Preferred Qualifications: 
<ul><li>3-7 years of related work experience.
</li><li>Experience in patient monitoring systems, hospital-based equipment, software or electronic devices.
</li><li>Good knowledge of the META Region regulations on electro-medical devices.
</li><li>Experience interacting with regulatory bodies.
</li><li>Proficient in document management systems, such as Oracle Agile PLM.
</li><li>Prior experience working within countries in Middle East &amp; Africa.
</li><li>Prior experience working in international organizations. 
</li></ul>Education: 
BA/BS Degree, or equivalent combination of education and experience is required. Preferred degrees in sciences, engineering, or biomedical engineering. 
Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?
Please send your full application.
To learn more about us, please visit: www.masimo.com</div>

Regulatory Affairs Specialist I

GoFundMe

<div>
 
 Want to help us help others? We&rsquo;re hiring!
 
 
 
 GoFundMe is the world&rsquo;s most powerful community for good, dedicated to helping people help each other. By uniting individuals and nonprofits in one place, GoFundMe makes it easy and safe for people to ask for help and support causes&mdash;for themselves and each other. Together, our community has raised more than $40 billion since 2010.
 
 
 Join us! The GoFundMe team is searching for our next Senior Regulatory Affairs Governance Analyst to help contribute to the development, implementation, and maturation of the organization&rsquo;s regulatory governance program, aligning compliance initiatives with evolving regulatory obligations, risk themes, and strategic priorities. You&rsquo;ll lead projects that shape the internal control environment, support oversight activities, and drive forward policy and governance frameworks.
 
 
 
 The Job
 
 
 
 <ul>
 <li>
 Shaping and refining compliance frameworks, operating models, and governance structures to support long-term program effectiveness Developing or supporting compliance metrics and reporting to monitor program health, identify gaps, and guide decision-making
 </li>
 <li>
 Conducting regulatory gap analyses, partnering with stakeholders to assess and document control effectiveness, and developing actionable recommendations to address areas of non-compliance or risk
 </li>
 <li>
 Leading and supporting policy and framework development by identifying regulatory requirements, coordinating reviews across stakeholders, and maintaining policy governance structures
 </li>
 <li>
 Advising cross-functional teams on regulatory expectations and internal compliance requirements during the development or enhancement of processes, systems, or products
 </li>
 <li>
 Designing and delivering compliance training to promote awareness, accountability, and understanding of regulatory obligations and internal standards
 </li>
 <li>
 Supporting the integrity of resiliency planning through coordination of documentation reviews and participation in testing
 </li>
 <li>
 Facilitating risk assessments, monitoring remediation plans, and reviewing program implementation to evaluate control design and effectiveness
 </li>
 <li>
 Preparing and delivering concise, well-structured reports and presentations to senior leadership and key stakeholders on compliance risks, trends, gaps, and remediation efforts
 </li>
 <li>
 Monitoring and synthesizing changes in the regulatory landscape, translating them into actionable insights and program updates
 </li>
 <li>
 Managing Second Line responses to regulatory inquiries, audits, and internal reviews by collaborating with business owners to compile documentation and address feedback
 </li>
 <li>
 Tracking the progress of compliance-related initiatives and providing constructive, risk-based feedback to teammates
 </li>
 <li>
 Building and maintaining collaborative relationships with internal stakeholders and external partners to promote a strong culture of compliance and proactively identify emerging risks
 </li>
 <li>
 Providing informal mentorship and support to peers by sharing knowledge, reviewing work, and contributing to team development
 
 
 </li>
 </ul>
 
 You
 
 
 
 <ul>
 <li>
 Bring 3+ years of experience in compliance, risk management, or a related governance role, ideally within a Second Line of Defense function
 </li>
 <li>
 Understand how to interpret regulatory requirements and translate them into clear, actionable guidance
 </li>
 <li>
 Communicate clearly and confidently, adapting your message for different audiences and levels of technical detail
 </li>
 <li>
 Are detail-oriented without losing sight of the bigger picture, especially when balancing regulatory expectations with operational realities
 </li>
 <li>
 Work independently, prioritize effectively, and take ownership of your deliverables
 </li>
 <li>
 Are energized by building and evolving programs, not just maintaining them
 </li>
 <li>
 Are comfortable navigating ambiguity and contributing to the development of new policies, frameworks, and documentation
 </li>
 <li>
 Build strong cross-functional relationships and influence outcomes through thoughtful collaboration
 </li>
 <li>
 Have experience supporting or working with global teams, and can adapt to different regulatory, cultural, or operational contexts
 </li>
 <li>
 Take pride in producing high-quality, strategic work that strengthens organizational compliance and enables long-term success
 
 
 </li>
 </ul>
 
 Why you&rsquo;ll love it here
 
 
 
 <ul>
 <li>
 Make an Impact: Be part of a mission-driven organization making a positive difference in millions of lives every year.
 </li>
 <li>
 Innovative Environment: Work with a diverse, passionate, and talented team in a fast-paced, forward-thinking atmosphere.
 </li>
 <li>
 Collaborative Team: Join a fun and collaborative team that works hard and celebrates success together.
 </li>
 <li>
 Competitive Benefits: Enjoy competitive pay and comprehensive healthcare benefits.
 </li>
 <li>
 Holistic Support: Enjoy financial assistance for things like hybrid work, family planning, along with generous parental leave, flexible time-off policies, and mental health and wellness resources to support your overall well-being.
 </li>
 <li>
 Growth Opportunities: Participate in learning, development, and recognition programs to help you thrive and grow.
 </li>
 <li>
 Commitment to DEI: Contribute to diversity, equity, and inclusion through ongoing initiatives and employee resource groups.
 </li>
 <li>
 Community Engagement: Make a difference through our volunteering program.
 
 
 </li>
 </ul>
 
 We live by our core values:
 
 
 impatient to be great
 
 ,
 
 find a way
 
 ,
 
 earn trust every day
 
 ,
 
 fueled by purpose
 
 . Be a part of something bigger with us!
 
 
 GoFundMe is proud to be an equal opportunity employer that actively pursues candidates of diverse backgrounds and experiences. We do not discriminate on the basis of race, color, religion, ethnicity, nationality or national origin, sex, sexual orientation, gender, gender identity or expression, pregnancy status, marital status, age, medical condition, mental or physical disability, or military or veteran status.
 
 
 The total annual salary for this full-time position is $75,000.00 - $112,000.00 + equity + benefits. As this is a remote position, the salary range was determined by role, level, and possible location across the US. Individual pay is determined by work location and additional factors including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range based on your location during the hiring process.
 
 
 If you require a reasonable accommodation to complete a job application or a job interview or to otherwise participate in the hiring process, please contact us at accommodationrequests@gofundme.com.
 
 
 
 Global Data Privacy Notice For Job Candidates And Applicants
 
 
 
 Depending on your location, the General Data Protection Regulation (GDPR) or certain US privacy laws may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here. By submitting your application, you are agreeing to our use and processing of your data as required.
 
 
 
 Learn More About GoFundMe
 
 
 
 We&rsquo;re proud to partner with GoFundMe.org, an independent public charity, to extend the reach and impact of our generous community, while helping drive critical social change. You can learn more about GoFundMe.org&rsquo;s activities and impact in their FY &lsquo;24 annual report.
 
 
 Our annual &ldquo;Year in Help&rdquo; report reflects our community&rsquo;s impact in advancing our mission of helping people help each other.
 
 
 For recent company news and announcements, visit our Newsroom.
 
 
 
 Notice to Applicants for Jobs Located in NYC or Remote Jobs Associated With Office in NYC Only
 
 
 
 We use Metaview as part of our hiring process for jobs in NYC and certain features may qualify it as an automated employment decision tool (AEDT), as defined by New York City Local Law 144. As part of the hiring process, we provide Metaview with job requirements and candidate submitted resumes and application materials to assist in evaluating job-related qualifications. While this tool is used to improve efficiency and support our recruiting personnel, all final hiring decisions are made by GoFundMe employees.
 
 
 We began using Metaview on March 10, 2026. The Metaview tool has been reviewed by an independent auditor. Results of the audit may be viewed here. The tool evaluates your professional experience, technical skills, education, and other qualifications using information collected directly from your submitted resume and application materials; all such data is retained in accordance with GoFundMe&rsquo;s Personnel Privacy Notice and applicable legal requirements. If you would like to request an alternative selection process or a reasonable accommodation, please contact accommodationrequests@gofundme.com.
 
 
</div>

Analyst II, Compliance Program

SPECTRAFORCE

<div>
 
 
 Position Title:
 
 Analyst, Data Analytics
 
 
 
 Work Location:
 
 Irvine, CA (Hybrid)
 
 
 
 Assignment Duration:
 
 12 Months
 
 
 
 
 
 
 Position Summary:
 
 
 
 Perform quantitative analysis using Python (e.g., pandas, NumPy, visualization libraries) to support clinical trial operations such as enrollment, costing, and resourcing, and to develop forecasting and decision-support outputs for key stakeholders (e.g., Clinical Affairs, Regulatory and Medical Affairs, Strategy, Global Supply Chain, Finance).
 
 
 Investigate, assess, and interpret clinical and operational data to support strategic decision-making, including early signal detection related to enrollment trends, protocol adherence, site performance, and data quality, while proposing moderately complex solutions and recommendations.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 
 &bull; Perform quantitative analysis using Python (e.g., pandas, NumPy, visualization libraries) to support clinical trial operations such as enrollment, costing, and resourcing, and to develop forecasting and decision-support outputs for key stakeholders (e.g., Clinical Affairs, Regulatory and Medical Affairs, Strategy, Global Supply Chain, Finance).
 
 
 &bull; Investigate, assess, and interpret clinical and operational data to support strategic decision-making, including early signal detection related to enrollment trends, protocol adherence, site performance, and data quality, while proposing moderately complex solutions and recommendations.
 
 
 &bull; Modify, extend, and maintain analysis tools and workflows&mdash;primarily in Python&mdash;by leveraging existing clinical models (e.g., inventory, case management, headcount, trial enrollment, site activations/deactivations) while applying clinical trial domain knowledge.
 
 
 &bull; Organize, analyze, and create reproducible analyses, reports, dashboards, and data extracts to summarize moderately complex challenges across clinical affairs projects, programs, and initiatives.
 
 
 &bull; Apply statistical methods (e.g., descriptive statistics, trend analysis, basic inferential methods) as appropriate to quantify uncertainty, monitor performance, and support interpretation of clinical and operational signals.
 
 
 &bull; Lead portions of clinical analytics projects in collaboration with cross-functional stakeholders (e.g., Clinical Operations, Biostatistics, vendors, and internal analytics partners).
 
 
 &bull; Identify and propose data-driven process improvements related to clinical affairs operations (e.g., screening efficiency, site start-up, physician training, data review workflows).
 
 
 &bull; Other duties as assigned.
 
 
 
 
 
 
 Qualification &amp; Experience:
 
 
 
 &bull; Bachelor's Degree Required
 
 
 &bull; 3 years of previous related experience Required
 
 
 &bull; Experience in a quantitative, analytical, or programming-heavy role Preferred
 
 
 &bull; Experience working in clinical research or clinical trial operations within the medical device industry Preferred
 
 
 &bull; Strong proficiency in Python for data analysis, including developing maintainable scripts and notebooks for clinical and operational datasets
 
 
 &bull; Proven expertise in Excel and PowerPoint and other MS Office Suite applications (Word, Access)
 
 
 &bull; Solid understanding of quantitative and statistical methodologies, with the ability to apply them pragmatically in a clinical operations context
 
 
 &bull; Experience with signal detection, trend monitoring, or anomaly identification in complex datasets preferred
 
 
 &bull; Good written and verbal communication skills and interpersonal relationship skills
 
 
 &bull; Strong problem-solving, organizational, analytical, and critical-thinking skills
 
 
 &bull; Moderate knowledge and understanding of client's policies, procedures, and guidelines relevant to clinical trial data analytics
 
 
 &bull; Strict attention to detail and data quality
 
 
 &bull; Ability to interact professionally with all organizational levels
 
 
 &bull; Ability to manage competing priorities in a fast-paced environment
 
 
 &bull; Ability to work collaboratively in team and cross-functional environments
 
 
 &bull; Ability to build productive internal and external working relationships
 
 
 &bull; Adhere to all company rules and requirements (e.g., Environmental Health &amp; Safety policies) and take appropriate measures to protect people, data, and the environment.
 
</div>

Analyst, Data Analytics

Veeva Systems

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company &ndash; we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva is looking for an experienced consultant to lead MedTech Regulatory Information Management (RIM) implementations at Veeva&rsquo;s MedTech customers globally. This role will guide the transformation of our customers&rsquo; Regulatory Affairs and Operations processes through industry-leading technology. The MedTech Regulatory consultant will work closely with Professional Services teams to ensure delivery success across the end-to-end regulatory process, covering both data and documentation related workstreams. What You'll Do Lead RIM implementation workstreams for Veeva&rsquo;s MedTech Regulatory solutions, ensuring successful customer adoption and system configuration Review and analyze existing customer business processes to identify key process steps, gaps, and requirements that impact the implementation approach Function as a primary customer liaison, managing complex communication between implementation teams, customer stakeholders, and third parties Analyze customer requirements and new product features to develop long-term adoption and enhancement roadmaps for Regulatory Operations Guide customers in adopting Veeva RIM and industry best practices, focusing on the continuous improvement of Regulatory data and document management Requirements 8+ years of experience in Systems Implementation, GxP Systems ownership, or Software Consulting 4+ years of experience working with or in Regulatory Operations or Regulatory Affairs specifically within the Medical Device or Diagnostics industry Direct experience with software implementation for Veeva RIM or similar solutions (e.g. RegDesk, RIMSYS, IQVIA, Kalypso, Essenvia) Strong understanding of global regulatory requirements, including FDA, EU MDR/IVDR, Technical Documentation structures and UDI reporting standards Proven track record leading IT operations or implementations as a consultant, business analyst, or business sponsor Excellent verbal and written communication skills, with the ability to design creative solutions for complex business requirements Nice to Have Direct Veeva Vault implementation experience Experience with Change Management and Management Consulting Experience with MedTech products or Medical Devices, In-Vitro Diagnostics, Software as a Medical Device (SaMD) or combination products Experience with UDI (Unique Device Identification) or global submission planning Perks &amp; Benefits Medical, dental, vision, and basic life insurance Flexible PTO and company paid holidays Retirement programs 1% charitable giving program Compensation Base pay: $80,000 - $200,000 The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus. #LI-Remote #LI-MidSenior Veeva&rsquo;s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Senior Consultant - MedTech Regulatory Implementation

Ghrasa Laboratory

We Are Hiring: DRAP Regulatory Affairs OfficerWe are looking for an experienced and detail-oriented DRAP Regulatory Affairs Officer to join our growing team and ensure full compliance with regulatory requirements for medical and laboratory equipment in Pakistan.Key Responsibilities:<ul><li>Manage product registrations with DRAP (Class A, B, C &amp; D devices)</li><li>Ensure compliance with DRAP rules, guidelines, and documentation</li><li>Prepare and submit regulatory dossiers and technical files</li><li>Liaise with DRAP officials and regulatory bodies</li><li>Monitor regulatory updates and implement changes internally</li><li>Support marketing team with compliant product claims and advertisements</li></ul>Requirements:<ul><li>Bachelor&rsquo;s/Master&rsquo;s in Pharmacy or relevant field</li><li>3&ndash;5 years of experience in DRAP regulatory affairs</li><li>Strong knowledge of DRAP regulations and medical device classification</li><li>Experience with product registration and licensing processes</li><li>Excellent documentation and communication skills</li></ul>What We Offer:<ul><li>Competitive salary package with other company benefits</li><li>Career growth in a rapidly expanding company</li><li>Professional and compliance-driven work environment</li></ul>Apply Now: Send your CV to: HR@ghrasa.com Whatsapp: 0317-3172913Only shortlisted candidates will be contactedWork Location: In person

DRAP Regulatory Affairs Officer

anekor

We are urgently hiring a Manager &ndash; Government Affairs for one of our clients in the manufacturing industry, based in Islamabad.Responsibilities<ul><li>Develop and maintain strong relationships with government departments and regulatory authorities</li><li>Ensure compliance with applicable laws, regulations, and government policies</li><li>Liaise with government bodies for approvals, licenses, permits, and documentation</li><li>Monitor policy and regulatory changes and assess their impact on business operations</li><li>Represent the organization in official meetings, forums, and engagements</li><li>Coordinate with internal departments for regulatory alignment and compliance</li><li>Manage government-related correspondence, reporting, and documentation</li><li>Support senior management in handling regulatory and strategic government matters</li></ul>Requirements<ul><li>Bachelor&rsquo;s or Master&rsquo;s degree in Public Administration, Political Science, Law, or a related field</li><li>5&ndash;8 years of experience in government affairs, regulatory affairs, or a similar role (manufacturing industry preferred)</li><li>Strong network with government and regulatory authorities</li><li>Excellent communication, negotiation, and interpersonal skills</li><li>Strong understanding of local laws, policies, and compliance frameworks</li><li>Ability to handle sensitive and confidential matters professionally</li></ul>Salary: 400K To 500K+ BenefitsLocation: IslamabadWork Location: In person

Manager Government Affairs

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