Regulatory Affairs Officer
MSS Med Surg Solutions
صاحب عمل نشط
نشرت قبل 9 ساعات
أرسل لي وظائف مثل هذه
الجنسية
أي جنسية
جنس
غير مذكور
عدد الشواغر
1 عدد الشواغر
الوصف الوظيفي
الأدوار والمسؤوليات
We are looking for a Regulatory Affairs Officer to ensure the company s full compliance with all applicable regulatory requirements in Bahrain. You will serve as the main point of contact with regulatory authorities, maintain up-to-date knowledge of all the regulatory information and requirements to ensure the continuous maintenance of compliance.
Key Responsibilities include but are not limited to:
- Serve as the main contact point for relevant regulatory bodies, essentially with NHRA, manage regulatory affairs activities, handle OFOQ Importation submissions, Ajheza platform Registration submissions and Variations and AR and CR renewal processes, follow up on Field Safety Notice events and recalls, and respond promptly to regulatory requests.
- Prepare, submit, and follow up on regulatory documentation, ensuring the necessary quality, accuracy, and adherence to all laws, guidelines, and regulatory requirements.
- Monitor, interpret, and communicate regulatory updates, advising internal teams on submission strategies and guiding colleagues on regulatory-related issues.
- Support regulatory audits and inspections, providing necessary documentation, coordinating preparations, and ensuring ongoing compliance.
- Maintain compliance through timely license renewals, product registrations, periodic updates, and by keeping an organized and up-to-date regulatory database and filing system.
- Evaluate changes to products, documents, processes, and services to determine regulatory requirements and suggest necessary adjustments.
Skills & Competencies:
- Proactive, with a commitment to continuous learning and sound decision-making.
- Strong communication, and interpersonal relationship building skills.
- Excellent planning, organizational, and problem-solving abilities.
Job Type: Full-Time
الملف الشخصي المطلوب للمرشحين
Requirements and Qualifications
- Bachelor s degree in science or a related field.
- 3-5 years of relevant experience in regulatory affairs.
- ROA certification (required).
- Knowledge of relevant regulatory rules and guidelines.
- Ability to collect and stay updated on regulatory requirements.
- Knowledge of processes and systems for tracking and maintaining regulatory submissions.
- Good analytical and problem-solving skills.
- Good proficiency in the English language
- Ability to work collaboratively in a team and take ownership of assigned tasks
القطاع المهني للشركة
- طب
- رعاية صحية
- تشخيص
- أجهزة طبية
المجال الوظيفي / القسم
- ادارة
الكلمات الرئيسية
- Regulatory Affairs Officer
تنويه: نوكري غلف هو مجرد منصة لجمع الباحثين عن عمل وأصحاب العمل معا. وينصح المتقدمون بالبحث في حسن نية صاحب العمل المحتمل بشكل مستقل. نحن لا نؤيد أي طلبات لدفع الأموال وننصح بشدة ضد تبادل المعلومات الشخصية أو المصرفية ذات الصلة. نوصي أيضا زيارة نصائح أمنية للمزيد من المعلومات. إذا كنت تشك في أي احتيال أو سوء تصرف ، راسلنا عبر البريد الإلكتروني abuse@naukrigulf.com
MSS Med Surg Solutions
At MSS, we promote a collaborative and inclusive work environment where employees feel valued, empowered, and inspired to excel. We prioritize professional growth, teamwork, and innovation, fostering a culture that drives continuous learning, creativity, and industry leadership. Our strong commitment to employee well-being and development ensures that every team member thrives in a dynamic and forward-thinking environment, where their contributions help shape the future of surgical excellence and patient care./p>
About Med Surg Solutions (MSS) p>Med Surg Solutions (MSS) is a leading force in medical innovation, specializing in surgical and intensive care solutions that redefine patient outcomes. With over two decades of expertise across the GCC, MSS has been instrumental in bringing cutting-edge technologies to the region, partnering with global healthcare leaders. Operating in KSA, UAE, Oman, Kuwait, Qatar, Bahrain, and Lebanon, we collaborate with government hospitals and private healthcare institutions to advance the healthcare ecosystem.br>
At MSS, lifelong support is embedded in our DNA. We go beyond product delivery by offering holistic solutions that span the entire patient journey, from preventive medicine to optimal treatment and post-recovery care. Our commitment to co-value solution propositions, incremental innovation, and clinical medical education ensures that we empower healthcare professionals with the knowledge, technology, and support needed to drive better patient outcomes.br>
Guided by our core values of excellence, integrity, and innovation, and led by CEO Fadi Mahmoud, MSS is committed to bridging the gap between breakthrough medical technologies and real-world healthcare needs. Our patient-centric approach ensures that every solution we deliver enhances surgical precision, improves recovery times, and elevates healthcare standards across the region.