Regulatory Affairs jobs in Mimaropa

What to Expect - - Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements. - Manage annual registrations, license renewals, and ongoing regulatory notifications. - Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation. - Coordinate the collection, review, and...

Lumira Search is partnered with an innovative medical device start-up in neuromodulation. We are looking to recruit a Director of Regulatory Affairs to join the team and drive global regulatory strategy during a pivotal stage for the company. Open to candidates based anywhere in Europe, this is a remote position with infrequent travel. Our client is well-funded and has developed a truly...

A global health and wellness company is seeking a Regulatory Affairs Specialist to ensure compliance across European markets. This fully remote position emphasizes strong organizational skills, attention to detail, and proficiency in English. The ideal candidate will maintain regulatory documentation and assist in product registrations while collaborating with cross-functional teams. Benefits...

Apsida Life Science are currently partnered with a highly innovative diagnostics company who are development next-generation technologies for the rapid and accurate detection of infections and contamination. The focus of their work has an incredibly positive social impact on the future of healthcare. With a strong portfolio of patents, multiple successful audits, an active clinical trial, and...

Lead AI & Automation in Regulatory Affairs – Transform How Therapies Reach Patients! We’re seeking a forward-thinking, science-savvy professional to drive AI-enabled regulatory dossier submission and automation initiatives. This is a high-impact role where you will combine your regulatory expertise, technical curiosity, and project leadership to accelerate regulatory processes and ensure...

A global healthcare company is seeking a Regulatory Affairs Specialist Lab Automation in the Philippines. The successful candidate will interface with regulatory authorities, create and verify compliance documentation, and ensure adherence to standards. Ideal applicants will have a Bachelor's degree in a relevant field and 2-5 years of experience in technical and regulatory documentation,...

Job Summary This role is responsible for leading and managing regulatory activities associated with EU Active Substances, substance defense, and related dossiers. The position ensures continuity of key programs (including high-value actives such as Napropamide) and provides strategic regulatory guidance within the EU framework. Depending on final organizational alignment, the role may interface...

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced...

Regulatory Manager / Senior Regulatory Manager Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep...

A leading medical device company in the Philippines seeks a Quality Assurance and Regulatory Affairs professional to implement and maintain their Quality Management System (QMS). This role requires at least 5 years of experience in the medical device industry, focusing on regulatory compliance and quality documentation. Key responsibilities include supporting audits and providing training for...

Are you an ambitious, hands on CMC regulatory expert? Strong knowledge and experience in biosimilars or wider biological products? If so, this could be the perfect career opportunity for you. This organisation operates across on a global level with significant geographical presence and is recognised as one of Europe’s leading developers of original and specialty medicines across several key...

A global life science company is seeking an experienced Regulatory Affairs Manager to lead regulatory submissions and compliance activities. The ideal candidate will have over 8 years of experience in regulatory affairs, with at least 4 years in a managerial role. Key responsibilities include engaging with regulatory authorities, conducting impact assessments, and ensuring compliance with EMEA...

OBJECTIVE AND MAIN TASK OF THE FUNCTION Key role in supporting the implementation, maintenance, and improvement of the STAAR ISO 13485 and MDR 2017/745-based Quality Management System (QMS) at STAAR Spain. This position also provides regulatory support (as the back up) to ensure compliance with EU MDR 2017/745 and Spanish medical device regulations. - Assist in designing, implementing, and...

A recruitment firm in the Life Science sector is looking for an experienced QA/RA professional. The ideal candidate will have over 5 years of experience in Regulatory Affairs and Quality Assurance, specifically in IVD product development. Responsibilities include developing regulatory strategies, preparing submissions, and managing communication with regulatory bodies. This role presents an...

Overview Lumira Search partnered with an innovative medical device start-up in interventional cardiology to recruit a Director of Clinical Affairs to execute the clinical study. Open to candidates based anywhere in Europe, with a strong preference to be based in the Netherlands or Germany. The company has developed a transformative medical device used in interventional cardiology...

Regulatory Affairs Specialist Lab Automation Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine...

Reports to: Senior Regulatory Affairs Manager, EMEA Location: Remote within the UK or Europe. Applications welcomed from candidates across the UK and EU (one position). Employment Type: Full-time, permanent About Partner.Co Partner.Co is a global health and wellness company that partners with independent Brand Partners to help people achieve a body, business, and lifestyle they love. Through...

An innovative medical device start-up is seeking a Director of Regulatory Affairs to develop and execute regulatory strategy. This remote position requires strong knowledge of EU MDR, good relationships with notified bodies, and regulatory experience in neuromodulation. Ideal candidates will thrive in a fast-paced environment and possess cross-functional leadership skills. The role will involve...

A leading life science consultancy in Romblon, España, is seeking an experienced professional in Regulatory Affairs for their team. The role involves conducting regulatory impact assessments, managing annual registrations, and supporting FDA dossier submissions. The ideal candidate should have at least 4 years of experience in the medical device industry, along with proven skills in global...

What to Expect - Line management, training of Regulatory Specialist - Training of the direct reports in EMEA / FDA requirements - Establish and manage regulatory submission timelines for both new and existing products across key global markets - Engage with regulatory authorities and distribution partners to support product registrations - Conduct global regulatory impact assessments for product...