regulatory affairs assistant

Boston Scientific

<div>Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we&rsquo;ll give you the opportunity to harness all that&rsquo;s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we&rsquo;ll help you in advancing your skills and career. Here, you&rsquo;ll be supported in progressing &ndash; whatever your ambitions. 
About the role: 
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.
The Regulatory Affairs Intern will support the entry, maintenance, and accuracy of Unique Device Identification (UDI) data within the Saudi Food and Drug Authority (SFDA) Saudi-DI system. This internship offers hands-on experience implementing SFDA MDS-REQ-007 guidance and exposure to regulatory processes in Saudi Arabia. You will collaborate with cross-functional teams to ensure data integrity and compliance with regulatory requirements. 
Your responsibilities will include:<ul><li> 
Enter and update UDI data in the Saudi-DI system in alignment with SFDA requirements</li><li>Maintain UDI trackers and ensure accurate documentation of submissions</li><li>Support the regulatory affairs team with UDI-related submissions and updates</li><li>Coordinate with internal stakeholders to resolve missing, incomplete, or inconsistent data</li><li>Follow established procedures and ensure compliance with quality and regulatory standards</li><li>Assist in improving data accuracy and process efficiency where applicable</li></ul> 
Qualifications:<ul><li> 
Currently pursuing a bachelor&rsquo;s degree in regulatory affairs, life sciences, biomedical engineering, or a related field</li><li>Strong attention to detail and organizational skills</li><li>Ability to follow instructions and adhere to established procedures</li><li>Basic proficiency in Microsoft Office tools, including Excel</li><li>Strong communication and collaboration skills</li></ul> 
Preferred qualifications:<ul><li> 
Familiarity with regulatory requirements or medical device industry standards</li><li>Interest in regulatory affairs and compliance within the healthcare industry</li></ul> 
Requisition ID: 628321 
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.</div>

The Regulatory Affairs Intern- Tamheer , Riyadh

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

K-Electric

<div>
 
 
 Purpose
 
 :
 
 
 To facilitate Regulatory Affairs team in day-to-day operations.
 
 
 
 
 
 
 Areas Of Responsibility:
 
 
 
 &bull; Assist in preparation of regulatory submissions and correspondence related to NEPRA based on detailed assessment of regulatory changes and its possible implications for KE.
 
 
 &bull; Provide support in addressing queries / drafting responses regarding on-going regulatory proceedings.
 
 
 &bull; Provide support to the line manager in ensuring regulatory compliance in consultation with internal stakeholders.&bull; Ensure timely and correct submission of Generation Concurrence cases to NEPRA after thorough scrutiny of received cases from Net Metering team
 
 
 &bull; Provide support to line manager / HoD on ad hoc assignments
 
 
 
 
 
 
 Required Education:
 
 
 
 &bull; Bachelors in relevant field
 
</div>

Project Trainee

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

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Cincinnati, Ohio, United States of America
Job Description:
About Surgery
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that&rsquo;s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world&rsquo;s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our active capital, energy-based business. This role will work a Flex/Hybrid schedule and be based in the Cincinnati, OH office. There is NO remote option and relocation assistance is not provided.
Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for MedTech Surgery. The individual combines knowledge of scientific, regulatory and business issues to ensure that products meet the required legislation the United States and global health authorities. Through your engagement in this role, you will help shape the surgical field.
You will be responsible for:<ul><li>
Prepare and submit regulatory documents, including applications for new product registrations and maintenance of existing registrations, to US FDA and EU Notified Bodies).</li><li>
Collaborate with global regulatory partners to drive innovation and prepare global regulatory submissions.</li><li>
Maintain device registrations and licenses throughout product lifecycle. Support product lifecycle. Evaluate proposed device changes for regulatory requirements and perform required regulatory submissions. Assist in the development of multi-country regulatory strategy.</li><li>
Monitor changes in regulations. Maintain and update strategy based upon regulatory changes in responsible jurisdictions.</li><li>
Provide regulatory support with teammates for internal and external audits (e.g. MDSAP).</li></ul>
Be passionate about Regulatory Affairs impact in research, development, clinical, marketing, and production of state-of-the-art medical devices.<ul><li>
Able to manage multiple overlapping priorities across projects.</li></ul>
Qualifications / Requirements:<ul><li>
Minimum of a Bachelor&rsquo;s Degree required. Science or Engineering discipline highly desired.</li><li>
At least 4+ years of related professional Regulatory Affairs experience required (2+ with Advanced Degree).</li><li>
Ability to comprehend principles of engineering, physiology and medical device use.</li><li>
Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.</li><li>
Exceptional self-education skills required, including proactive and comprehensive research of new and existing regulations, processes, and tools before requesting assistance.</li><li>
Strong verbal communication and regulatory/medical writing skills.</li><li>
Ability to effectively manage multiple projects and priorities.</li><li>
Exhibit leadership traits such as a positive, forward looking appraoch to problem-solving, and accountable, action-oriented, appraoch to deliver results. Results oriented and ability to meet project schedules.</li><li>
Enjoy teamwork and thrive as a member of cross-functional teams.</li><li>
Be adaptable and thrive in a dynamic work environment where variety is the routine.</li><li>
Experience with US Class II device submissions .</li><li>
Experience with active medical devices, including software, cybersecurity and electromagnetic evaluation submissions, preferred.</li><li>
Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus.</li><li>
Travel up to 10%.</li></ul>
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is :
$92,000.00 - $148,350.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)). 
 
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 
 
Vacation &ndash;120 hours per calendar year 
 
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado &ndash;48 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year 
 
Holiday pay, including Floating Holidays &ndash;13 days per calendar year 
 
Work, Personal and Family Time - up to 40 hours per calendar year 
 
Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child 
 
Bereavement Leave &ndash; 240 hours for an immediate family member: 40 hours for an extended family member per calendar year 
 
Caregiver Leave &ndash; 80 hours in a 52-week rolling period10 days 
 
Volunteer Leave &ndash; 32 hours per calendar year 
 
Military Spouse Time-Off &ndash; 80 hours per calendar year 
 
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid</div>

Senior Regulatory Affairs Specialist - MedTech Surgery

Kraft Heinz

<div>
 The Kraft Heinz Company is looking for a Scientific and Regulatory Affairs Specialist who will support scientific and regulatory activities to help ensure products comply with applicable regulations and internal standards. This role will collaborate cross-functionally to review product formulations, ingredients, labeling, and claims; prepare and maintain regulatory documentation; monitor regulatory changes; and provide guidance to internal stakeholders throughout product development and commercialization. The ideal candidate has a strong foundation in food science and regulatory requirements, excellent attention to detail, and the ability to communicate clearly with partners across R&amp;D, Quality, Legal, and Commercial teams.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Responsible for providing timely compliance input to all projects and ensure it meets and aligns with food compliance related laws, legislation, and regulations across Africa &amp; Trade markets
 </li>
 <li>
 Responsible to give compliance guidance in work streams, and to follow up, verify and validate execution of such actions by stakeholders
 </li>
 <li>
 Accountable for validating that ingredients, formulas, labelling, and claims are in full compliance with laws and regulations in markets been sold
 </li>
 <li>
 Communicate anticipated issues and provide regulatory support and compliance guidance for projects handled to the relevant stakeholders and forums
 </li>
 <li>
 Support a proactive strategic approach in regulatory function to identify, monitor, analyze early signals of upcoming regulations that might have impact in A&amp;T market, categorize them as per their likelihood and potential impact for the business.
 </li>
 <li>
 Build and maintain relationships with the relevant industrial groups and authorities to maintain awareness of new food legislations.
 </li>
 <li>
 Track- monitor and report on the completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.
 </li>
 <li>
 Drive cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products.
 </li>
 <li>
 Proactively identify and communicate SRA risk in any project or work stream
 </li>
 <li>
 Accountable to ensure risk assessment and mitigation plans are communicated to stakeholders
 </li>
 <li>
 Lead the registration process, collecting relevant documents, and keeping track of license expiration for the relevant SSA markets
 </li>
 <li>
 Drive a culture of scientific and regulatory affairs adherence to internal and external compliance processes and practices, driving continuous improvements opportunities
 </li>
 <li>
 Provide technical and legal labelling Information and support artwork approval process
 </li>
 <li>
 Ensure consistency and synergy in label &amp; declarations on packaging across A&amp;T markets (especially shared artworks)
 </li>
 <li>
 Scientific and regulatory affairs representation in all projects driven forums
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Biotechnology, or Food Science
 </li>
 <li>
 5 years of experience in regulatory compliance/affairs preferably within a food, beverage, or consumer sector
 </li>
 <li>
 Experience working with Microsoft programs and system tools related to recipes and artworks
 </li>
 <li>
 Experience in translation is preferred
 </li>
 <li>
 Fluent in Arabic &amp; English, French is a plus
 </li>
 </ul>
</div>

Scientific & Regulatory Affairs Specialist – Africa & Trading

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