regulatory affairs officer

Specialized Seamless Services (SSS)

<div>
 
 Job Summary:
 
 
 
 We are seeking a Regulatory Affairs and QA Officer to support regulatory submissions, ensure compliance with SFDA regulations, and maintain quality standards for medical devices and IVD products. The role requires coordination with manufacturers and internal teams to ensure timely product registration and regulatory compliance. The vacancy will offshore based in favor of Samir Group -
 
 KSA
 
 
 
 
 Key Responsibilities:
 
 
 
 <ul>
 <li>
 Support SFDA regulatory submissions (including MDMA applications).
 </li>
 <li>
 Prepare, review, and update regulatory documentation.
 </li>
 <li>
 Assist in product classification according to SFDA requirements.
 </li>
 <li>
 Monitor SFDA regulatory updates and communicate required actions internally.
 </li>
 <li>
 Maintain and update RA &amp; Quality databases and documentation.
 </li>
 <li>
 Ensure compliance with internal quality procedures.
 </li>
 <li>
 Coordinate with manufacturers and cross-functional teams.
 
 
 </li>
 </ul>
 
 Requirements:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Quality Management or related field.
 </li>
 <li>
 3&ndash;5 years of experience in Regulatory Affairs in the medical field is a must.
 </li>
 <li>
 Knowledge of SFDA regulations for medical devices and IVD is preferred.
 </li>
 <li>
 Internal audit certification is a plus.
 </li>
 <li>
 Strong proficiency in MS Office (Outlook, Word, Excel).
 </li>
 <li>
 Advanced English (writing: must, speaking: preferred).
 </li>
 </ul>
</div>

Regulatory Affairs Officer

Sanofi

<div>EM&amp;S Turkey Regulatory Affairs Officer<ul><li>
Location: Istanbul</li></ul>
About the job
Reporting to the EM&amp;S Middle East Quality Manager, the Regulatory Affairs Officer supports regulatory compliance and lifecycle activities related to External Manufacturing &amp; Supply operations. The role ensures alignment between regulatory dossiers and industrial practices at CMO, in compliance with local regulations and Sanofi standards, and acts as a key interface between Affiliate Regulatory Affairs and CMO.
This position contributes to the implementation of Sanofi&rsquo;s Quality and Regulatory policies within External Manufacturing &amp; Supply activities, ensuring regulatory compliance of manufactured products, supporting product lifecycle management, and enabling timely execution of regulatory-impacting changes and transfers.
Main responsibilities:<ul><li>
Regulatory Compliance &amp; Lifecycle Management<ul><li>
Ensure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOs</li><li>
Coordinate the regulatory compliance exercise with the assigned Hub</li><li>
Maintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)</li><li>
Support the preparation, maintenance, and update of CMC dossiers for assigned products</li><li>
Assess the regulatory impact of proposed changes (change controls) originating from CMO or internal sites</li><li>
Support Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs&hellip;)</li><li>
Contribute to the implementation of Sanofi Quality policy across External Manufacturing activities</li></ul></li><li>
Regulatory Interface &amp; Submissions Support<ul><li>
Act as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the Hub</li><li>
Consolidate industrial and technical data required for local and regional registrations and variations</li><li>
Support responses to Health Authority requests (RFI, deficiency letters)</li><li>
Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelines</li><li>
Perform regulatory review and approve documentation provided by the Hub prior to submission while ensuring documentation management within Sanofi systems (Veeva Vault)</li><li>
Manage regulatory activities in Veeva Vault (Regulatory Objective, SCP&hellip;)</li><li>
Participate in Quality System activities, including Change Control, CAPA, PQR, training, and documentation management</li><li>
Support regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teams</li><li>
Prepare the Variation Record Card (VRC) for product divestments</li></ul></li><li>
Site Compliance &amp; Regulatory Maintenance<ul><li>
Compile and maintain product specification files and support updates of the Site Master File (SMF)</li><li>
Support the maintenance of manufacturing licenses, GMP certificates, site registrations, and renewals</li><li>
Participate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activities</li><li>
Contribute to continuous improvement initiatives related to Regulatory Affairs processes and procedures</li></ul></li><li>
HSE &amp; Compliance Awareness<ul><li>
Ensure compliance with applicable HSE rules and procedures</li><li>
Report accidents and incidents occurring in the workplace in line with internal requirements</li><li>
Support site and Quality initiatives promoting compliance and quality culture (Quality Day)</li></ul></li><li>
Compliance &amp; Ethics<ul><li>
Comply with the Company's Code of Ethics, upholding high professional standards of conduct</li><li>
Demonstrate a commitment to protecting and enhancing the Company's reputation</li><li>
Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role</li><li>
Apply ethical principles and governance standards to all work activities</li></ul></li></ul>
About you
<ul><li>Education: Bachelor&rsquo;s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field</li><li>
Experience: At least 5 years&rsquo; experience in the pharmaceutical industry, preferably with 2 years+ in a similar role, working in a regulatory team.<ul><li>
Proven ability to manage multiple priorities effectively</li><li>
Experience in management of change control with regulatory impact</li></ul></li><li>
Skills:
<ul><li>Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)</li><li>
Understanding of CMC dossiers, variations, and product lifecycle management</li><li>
Familiarity with External Manufacturing / CMO environments is a plus</li><li>
Working knowledge of Quality Systems (Change Control, CAPA)</li><li>
Ability to compile, review, and manage technical and regulatory documentation</li><li>
Comfortable using digital tools (Excel, PowerPoint, and regulatory document management systems)</li></ul></li><li>
Languages: Fluency in English is required, knowledge of other languages is an asset</li></ul>
Why choose us?<ul><li>
Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.</li><li>
Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.</li></ul>
#LI-EUR
null</div>

EM&S Turkey Regulatory Affairs Officer

Fresenius Medical Care

<div>
 At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision&mdash;&ldquo;Creating a future worth living. For patients. Worldwide. Every day.&rdquo;&mdash;we work with purpose and compassion, supported by a global team of over 125,000 employees.
 
 
 Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
 
 
 Our values guide how we work:
 
 
 
 <ul>
 <li>
 We Care for our patients, each other, and our communities
 </li>
 <li>
 We Connect across teams and borders to deliver excellence together
 </li>
 <li>
 We Commit to doing things the right way&mdash; growing with purpose and leading kidney care with integrity and innovation
 
 
 
 </li>
 </ul>
 Systems, Quality &amp; Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care&rsquo;s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!
 
 
 Your Responsibilities:
 
 
 
 <ul>
 <li>
 Perform all country/region regulatory activities, ensuring product conformity, safety, post-market surveillance, and alignment with corporate SysQaRa and Quality functions
 </li>
 <li>
 Drive market access by preparing/adapting registration dossiers, managing submissions with consultants/TPIs, supporting due diligence, and enabling timely, compliant approvals for new and existing products
 </li>
 <li>
 Act as the primary regulatory key person, providing strategic guidance, risk assessments, and updates on national/regional regulatory requirements, while ensuring internal implementation and database maintenance
 </li>
 <li>
 Submitting notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
 </li>
 <li>
 Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements.
 </li>
 <li>
 Create and maintain local/regional registration database
 </li>
 <li>
 Identify regulatory and compliance risks, propose mitigation strategies, and track CAPAs resulting from internal or TPI audits
 </li>
 <li>
 Serve as PVRP or PV contact for assigned countries, interfacing with authorities, healthcare professionals, distributors, and CDS, and acting as the PV lead during audits/inspections
 </li>
 <li>
 For countries acting as PVRP, preparation of CAPAs for audit findings and process deviations, collection and forwarding of AE/ADRs and completion of quarterly compliance reports; for countries acting as PV point of contact, ensure preparation of CAPAs for audit findings and process deviations by the distributor and/or consultant, follow up of necessary AE/ADR collection and quarterly compliance report preparations to be performed by the related TPIs/contractors.
 </li>
 <li>
 Performing implementation and maintenance of Pharmacovigilance Agreements
 
 
 
 </li>
 </ul>
 Your Profile:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy, Chemistry, Biology, Bioengineering, Health Sciences, or another relevant scientific discipline
 </li>
 <li>
 At least 5 years of professional experience in regulatory affairs and at least 2 years in pharmacovigilance
 </li>
 <li>
 Results-driven professional with a structured approach, strong problem-solving and analytical skills, and the ability to handle pressure and prioritize effectively. Excellent communicator, independent worker, and solution-focused in achieving quality outcomes
 </li>
 <li>
 Demonstrated drive for process improvement and continuous optimization
 </li>
 <li>
 Solid knowledge of pharmacovigilance and pharmaceutical legislation
 </li>
 <li>
 Proficient in English (spoken and written)
 
 
 
 </li>
 </ul>
 Our Offer for you:
 
 
 There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
 
 
 
 <ul>
 <li>
 Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
 </li>
 <li>
 Individual opportunities for self-determined career planning and professional development
 </li>
 <li>
 A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
 </li>
 <li>
 A large number of committed people with a wide range of skills, talents and experience
 </li>
 <li>
 The benefits of a successful global corporation with the collegial culture of a medium-sized company
 </li>
 </ul>
</div>

Regulatory and Pharmacovigilance Senior Expert

PROPERTY SHOP INVESTMENT LLC - HQ

Job Summary:The Government Relations Officer manages all company interactions with government entities and regulatory authorities to ensure full legal compliance. This role oversees the issuance, renewal, and amendment of trade licenses, real estate brokerage licenses, civil defense and security permits, drone and aviation approvals, and tenancy registrations. The position manages company vehicles, employee residencies, health insurance, and maintains accurate documentation across all government systems. Through strong communication with ministries, municipalities, and free zone authorities, the officer ensures compliance with all UAE laws and administrative procedures.Key Responsibilities &amp; Accountabilities:Trade &amp; Business Licenses<ul><li>Handle the issuance, renewal, amendment, and cancellation of the company&rsquo;s trade licenses.</li><li>Obtain and renew real estate brokerage licenses for both the company and employees.</li><li>Ensure full compliance with all requirements set by DMT, ADDED, ADREC, ADGM, RA, Free Zones, etc.</li></ul>Vehicle &amp; Fleet Administration <ul><li>Handle complete administration for company vehicles, including registration, insurance renewal, parking permits, Salik, and advertising permits.</li><li>Handle all traffic fines and penalties, monitor, report, and process payments with the finance department.</li><li>Maintain detailed logs and monthly reports on vehicle renewals, fines, and insurance status.</li></ul>Employee &amp; HR Documentation (ADGM) <ul><li>Handle all employee-related processes within ADGM (visas, renewals, cancellations, employment contracts, access passes).</li><li>Coordinate with HR and management to maintain accurate employee profiles within the ADGM system.</li></ul>Property &amp; Tenancy Management <ul><li>Manage all tenancy contract registrations, renewals, amendments, and cancellations through Dari and ADGM Tawtheeq systems.</li><li>Coordinate with the leasing and property management departments to ensure accurate and up-to-date tenancy records.</li></ul>Health Insurance Management <ul><li>Oversee the end-to-end management of employee health insurance, including policy issuance, renewal, and maintenance.</li><li>Coordinate with providers and HR to ensure comprehensive coverage that complies with UAE regulations.</li></ul>Safety &amp; Security Compliance <ul><li>Process all Civil Defense applications, renewals, and approvals &amp; maintain valid certificates for all locations.</li><li>Handle all applications and renewals for security permits and access approvals (e.g., National Guard).</li></ul>Specialized Operations (Drones) <ul><li>Manage all applications for drone registration, aerial photography, and flight permits with GCAA, MOD, etc.</li><li>Secure and maintain all necessary pre-operational security clearances and approvals.</li><li>Maintain detailed records of all drones, flight approvals, renewals, and related correspondence.</li></ul>Government Relations &amp; Master Tracking <ul><li>Maintain active communication with all government entities (MOHRE, ADGM, DMT, RTA, TAMM, Civil Defense).</li><li>Systematically track expiry dates of all official documents to ensure timely renewals.</li><li>Regularly update HR and management with new governmental laws, procedures, or system changes.</li><li>Update government systems and internal trackers daily with accurate information and progress status.</li><li>Provide regular updates and reports to supervisors on application statuses and overall progress.</li></ul>Education and Skills<ul><li>Bachelor&rsquo;s degree in public relations, Communications, or related field</li><li>Excellent knowledge of UAE government online portals and processes</li><li>Strong attention to detail and organizational skills</li><li>Ability to maintain accurate electronic records and databases.</li></ul>Work Experience<ul><li>Minimum 1-3 years of experience in government relations or corporate communications</li><li>Proven experience with online government submission systems</li><li>Good understanding of labor and immigration regulations</li><li>Proficient in digital documentation and tracking systems.</li><li>Strong follow-up and time management abilities</li></ul>Job Type: Full-timeApplication Question(s):<ul><li>Can you join immediately?</li><li>Are you fluent in Arabic and English?</li><li>Share resume with professional photo on it</li></ul>Experience:<ul><li>Government Relations Officer : 2 years (Required)</li></ul>Location:<ul><li>Abu Dhabi (Required)</li></ul>Work Location: In person

Government Relations Officer

Savills

<div>We are seeking a competent Government Relations Officer who will focus on ensuring Savills&rsquo; full compliance with all labor related and immigration requirements for all its entities in KSA. They will provide end to end government relations support to the company within a timely manner whilst ensuring a proactive and commercial approach at all times. They will be organized and able to prepare and process paperwork/documents and relevant applications with minimal supervision, with strong customer service experience.
Key Responsibilities<ul><li>
Support HR Team in processing all new Iqamas and work permits for expats to guarantee that they are handled and processed on time.</li><li>
Support existing projects with tracking the issuance and renewals of iqama and exit/re-entry visas for new and existing personnel Monitor and administer government portals as necessary (General Organization of Social Insurance (GOSI), Ministry of Human Resources and Social development platforms such as Qiwa, and Mudad (MHRDS), Chamber of Commerce (COC), Saudi Post , Ministry of Commerce , Wage Protection System (WPS),Ministry of Foreign Affairs (MOFA), Human Resources Development Fund (HRDF), Taqat, and Ministry of Investment (MISA),REGA.</li><li>
Renew and update all Iqamas and work permits to guarantee records are kept up to date in the labor and Immigration Departments.</li><li>
Visit offices for signatures, document collection and drop-off to ensure high levels of service.</li><li>
Liaise with HR and administration team members across the regional business, as required.</li><li>
Represent the Company at locations such as the Police Station, Airport, Hotels, Embassies, Ministries/Municipalities and other significant Departments.</li><li>
Track all licenses and portals and ensure that are all valid.</li><li>
Support the registration of new joiners and leavers with General Organization of Social Insurance (GOSI), Qiwa and Mudad.</li><li>
Attend meetings as required with representatives from any governmental bodies like TAQEEM, MISA, GOSI MOHR, Municipality, Balday, HRDF at the office and ensure that all requirements are ready and in compliance.</li><li>
Tracker MOHR portal to ensure that required Saudization percentage for partially localized jobs are met.</li><li>
Coordinate with government authorities to Adhere to existing and new rules, reporting any changes/updates to Management.</li><li>
Provide best in class service delivery and communication to employees or other stakeholders in timely manner.</li><li>
Facilitate Visa transfer and overseas work visa processes from start to finish.</li><li>
Stay current on any changes or amendments to immigration laws/rules/regulations, changes in forms/formats and other procedures and keep stakeholders/HR team aware of such changes</li><li>
Complete departure and exit procedures for employees after cancellation of visas</li><li>
Keep abreast of any changes or amendments to the prevailing Labor laws/rules/ regulations, changes in forms and other procedures.
</li><li>Keep the HR management advised of such changes and highlight any potential risk or financial concern.</li><li>
Develop relationships with Government Departments in order to ensure issues are resolved diligently.</li><li>
Process attested documentation such as trade licenses, rent contracts etc. in government offices and visit them if required.</li><li>
Support with any adhoc administrative and logistical support to the wider KSA team, including attending to emergencies in a timely manner as required.</li><li>
Keep track of all relevant Savills KSA licenses to ensure validity and full compliance.</li><li>
Maintain portals for all entities, to ensure data is up to date and compliant.</li><li>
Assist with adhoc translation service requests, as required.</li></ul>
Skills, Knowledge and Experience<ul><li>
This role must meet Saudization commitments.</li><li>
Ideally educated to High School/College level as a minimum.</li><li>
Minimum 3 years of relevant work experience in KSA, in a similar role.</li><li>
Fluent command in Arabic and competent in written &amp; spoken English.</li><li>
Trustworthy, hardworking and reliable.</li><li>
Proactive in nature, with problem-solving ability.</li><li>
Can work independently and have interest in developing knowledge in this discipline regularly.</li><li>
Good Administration/Computer skills</li><li>
Structured and organized in time management</li><li>
Good communicator, who pays attention to detail.</li><li>
Good knowledge of all KSA labor and governmental platforms.</li><li>
Comprehensive knowledge and understanding of KSA labor laws, governmental bodies direction and related regulations</li><li>
Well-developed interpersonal skills, ability to build and sustain relationships with clients and colleagues</li><li>
Ability to work on own initiative and have a proactive, positive approach</li><li>
Flexibility and adaptability to juggle a range of different tasks and to work extra hours to meet deadlines</li><li>
Discretion and understanding of confidentiality issues</li></ul></div>

Governmental Relations Officer

<div><div>We help the world run better 
At SAP, we keep it simple: you bring your best to us, and we'll bring out the best in you. We're builders touching over 20 industries and 80% of global commerce, and we need your unique talents to help shape what's next. The work is challenging &ndash; but it matters. You'll find a place where you can be yourself, prioritize your wellbeing, and truly belong. What's in it for you? Constant learning, skill growth, great benefits, and a team that wants you to grow and succeed.</div><div></div> 
What you&rsquo;ll build
<ul><li>Manage all government transactions, including visa processing, Iqama issuance/renewals, and commercial license applications.</li><li>Liaise and coordinate with ministries, government authorities, and regulatory bodies.</li><li>Process and manage transactions through relevant government online portals (e.g., Muqeem, Absher, Qiwa, etc.).</li><li>Prepare, submit, and track documentation related to employee and company legal requirements.</li><li>Maintain accurate and up-to-date records of employee legal and governmental documents.</li><li>Represent the company professionally in dealings with Labour government entities.</li><li>Monitor Employment regulatory updates and ensure full compliance with Saudi laws and regulations.</li></ul> 
What you bring:
<ul><li>Proven experience as a Government Relations Officer (GRO) in KSA.</li><li>Strong knowledge of Saudi labor law, immigration procedures, and commercial regulations.</li><li>Fluency in Arabic and English (spoken and written).</li><li>Valid Saudi driving license.</li><li>Proficient in MS Office and government portal systems.</li></ul> 
Where you belong:
You will be part of the MEA North Strategy Office and working closely with internal stakeholders including People and Culture Team. 
<div>Bring out your best 
SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has evolved to become a market leader in end-to-end business application software and related services for database, analytics, intelligent technologies, and experience management. As a cloud company with two hundred million users and more than one hundred thousand employees worldwide, we are purpose-driven and future-focused, with a highly collaborative team ethic and commitment to personal development. Whether connecting global industries, people, or platforms, we help ensure every challenge gets the solution it deserves. At SAP, you can bring out your best.
 
 
We win with inclusion 
SAP&rsquo;s culture of inclusion, focus on health and well-being, and flexible working models help ensure that everyone &ndash; regardless of background &ndash; feels included and can run at their best. At SAP, we believe we are made stronger by the unique capabilities and qualities that each person brings to our company, and we invest in our employees to inspire confidence and help everyone realize their full potential. We ultimately believe in unleashing all talent and creating a better world. 
 
SAP is committed to the values of Equal Employment Opportunity and provides accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with SAP and are in need of accommodation or special assistance to navigate our website or to complete your application, please send an e-mail with your request to Recruiting Operations Team: Careers@sap.com. 
 
For SAP employees: Only permanent roles are eligible for the SAP Employee Referral Program, according to the eligibility rules set in the SAP Referral Policy. Specific conditions may apply for roles in Vocational Training. 
 
Qualified applicants will receive consideration for employment without regard to their age, race, religion, national origin, ethnicity, gender (including pregnancy, childbirth, et al), sexual orientation, gender identity or expression, protected veteran status, or disability, in compliance with applicable federal, state, and local legal requirements. 
 
Successful candidates might be required to undergo a background verification with an external vendor.</div><div></div><div> 
AI Usage in the Recruitment Process</div><div>
For information on the responsible use of AI in our recruitment process, please refer to our Guidelines for Ethical Usage of AI in the Recruiting Process.
</div>Please note that any violation of these guidelines may result in disqualification from the hiring process. 
 
Requisition ID: 445857 | Work Area: Administration | Expected Travel: 0 - 10% | Career Status: Graduate | Employment Type: Limited Full Time | Additional Locations: #LI-Hybrid</div>

Government Relations Officer (One-Year Fixed-Term Contract)

Custom Health

<div>Description:

About Custom Health
Custom Health is a fully integrated health technology company delivering patient-centric healthcare as a service. Our mission is to transform the patient experience for individuals receiving care at home by improving health outcomes while reducing the total cost of care.
Powered by a modern purpose-built technology platform, high-volume central fill pharmacy operations, and an integrated clinical care team, Custom Health delivers optimized and personalized care for patients in the home with precision and scale.
Custom Health operates across the United States and Canada, supporting regulated healthcare services, pharmacy operations, digital health platforms, and medical device technologies.
Position Overview
The Chief Compliance &amp; Regulatory Officer (CCRO) is responsible for leading enterprise-wide compliance, regulatory affairs, and quality governance across Custom Health, Inc. and its subsidiaries.
The CCRO establishes and maintains the company&rsquo;s global compliance framework, ensuring that all operations comply with applicable healthcare, pharmaceutical, medical device, privacy, and corporate governance regulations across jurisdictions in which the company operates.
Reporting directly to the Chief Executive Officer, with a dotted-line reporting relationship to the Board of Directors through the Audit &amp; Compliance Committee, the CCRO serves as the independent executive authority responsible for regulatory compliance, ethics, and quality oversight.
The role provides executive oversight of regulatory and quality systems supporting regulated healthcare services, digital health platforms, and medical device operations, ensuring compliance with U.S. FDA regulations, Health Canada requirements, ISO standards, and applicable global regulatory frameworks.
The CCRO also supports public company governance obligations, including regulatory disclosure risk management, internal controls, and compliance oversight expected of a TSX-listed organization.
Key Responsibilities
Enterprise Compliance &amp; Ethics Governance:<ul><li>
Develop and maintain the enterprise-wide compliance and ethics program across Custom Health, Inc. and all subsidiaries.</li><li>
Establish governance structures, policies, and procedures supporting regulatory compliance, corporate integrity, and ethical conduct.</li><li>
Promote a culture of accountability, transparency, and compliance throughout the organization.</li><li>
Ensure compliance functions operate with appropriate independence from operational management.</li></ul>
Regulatory Affairs &amp; Medical Device Compliance:<ul><li>
Provide executive oversight for regulatory strategy and compliance related to medical devices, digital health technologies, and regulated healthcare services.</li><li>
Ensure compliance with U.S. FDA regulations (including 21 CFR Part 820 Quality System Regulation), Health Canada Medical Device Regulations, and other applicable international regulatory frameworks.</li><li>
Oversee regulatory submissions, approvals, certifications, and lifecycle management.</li><li>
Serve as executive liaison with regulatory agencies, notified bodies, and external auditors.</li></ul>
Quality Systems &amp; ISO Compliance:<ul><li>
Ensure implementation and continuous improvement of enterprise Quality Management Systems (QMS).</li><li>
Maintain compliance with ISO 13485 and other applicable quality and regulatory standards.</li><li>
Oversee quality governance related to product development, manufacturing, distribution, and post-market surveillance.</li><li>
Ensure corrective and preventive action (CAPA), complaint handling, and regulatory reporting processes are properly implemented.</li></ul>
Healthcare Compliance &amp; Privacy:<ul><li>
Ensure enterprise compliance with HIPAA, healthcare privacy regulations, and applicable federal and state healthcare laws.</li><li>
Maintain oversight of compliance with Stark Law, Anti-Kickback Statute, and healthcare fraud and abuse regulations.</li></ul>
Enterprise Risk &amp; Compliance Monitoring:<ul><li>
 Conduct enterprise compliance risk assessments and regulatory gap analyses.</li><li>
Identify, assess, and mitigate regulatory, operational, and reputational risks.</li><li>
Establish monitoring and auditing frameworks to ensure ongoing compliance.</li></ul>
Auditing, Investigations &amp; Corrective Actions:<ul><li>
Oversee internal compliance audits and regulatory readiness assessments.</li><li>
Lead investigations into potential compliance violations.</li><li>
Ensure implementation of corrective and preventive actions and regulatory remediation programs.</li></ul>
Compliance Training &amp; Code of Conduct:<ul><li>
Develop and maintain enterprise compliance education and training programs.</li><li>
Maintain the company&rsquo;s Code of Conduct and ethics reporting systems, including confidential reporting channels.</li><li>
Strategic Initiatives &amp; Mergers and Acquisitions</li><li>
Provide compliance and regulatory oversight for corporate strategy, partnerships, and acquisitions.</li><li>
Conduct regulatory and compliance due diligence for mergers and acquisitions.</li><li>
Ensure acquired entities are integrated into the enterprise compliance and quality framework.</li></ul>
Board Governance &amp; Public Company Compliance:<ul><li>
 Provide regular reports to the Board of Directors and Audit &amp; Compliance Committee regarding compliance program effectiveness.</li><li>
Report on regulatory developments, investigations, audit outcomes, and enterprise risk exposure.</li><li>
Support compliance with public company governance standards, disclosure controls, and regulatory reporting obligations.</li><li>
Ensure strong corporate governance practices aligned with TSX-listed company expectations.</li></ul>
Requirements: 
Qualifications<ul><li>
Bachelor&rsquo;s degree required with an advanced degree preferred (JD, Master&rsquo;s degree, or equivalent).</li><li>
Professional certification preferred (CHC, CCEP, RAC, or equivalent).</li><li>
15+ years of senior leadership experience in healthcare compliance, regulatory affairs, or quality systems.</li><li>
Experience within medical device, digital health, pharmacy services, or healthcare technology sectors.</li><li>
Experience interacting with regulatory authorities, boards of directors, and executive leadership teams.</li><li>
Experience supporting public company governance or companies preparing for public listing preferred.</li></ul>
Knowledge:<ul><li>
FDA medical device regulations and Quality System Regulation (21 CFR Part 820)</li><li>
Health Canada medical device regulatory frameworks</li><li>
ISO 13485 quality management systems</li><li>
HIPAA and healthcare privacy regulations</li><li>
Stark Law and Anti-Kickback Statute</li><li>
Healthcare fraud and abuse laws</li></ul>
Skills:<ul><li>
Strong executive leadership and regulatory strategy capabilities</li><li>
Deep expertise in compliance risk management and regulatory governance</li><li>
Ability to engage effectively with regulators, executive leadership, and boards of directors</li><li>
Excellent communication and organizational leadership skills</li></ul></div>

Chief Compliance & Regulatory Officer (CCRO)

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