Regulatory Affairs Manager
Vor 7 Tagen
Regulatory Affairs Manager Location: CambridgeshireEmployment Type: (Full-time: Mon-Fri) (Hybrid: 2 - 3 days on site) We are seeking an experienced Regulatory Affairs Manager to lead global regulatory activities across a product portfolio and ensure the products remain safe, effective, and compliant for worldwide markets. This is an exciting opportunity for a proactive regulatory professional to shape regulatory strategy, influence product development, and play a key leadership role within the RA department. What you’ll be doing Lead regulatory strategies and submissions for new and updated products. Act as the regulatory lead and SME for product development projects, providing solution-focused guidance. Review and approve technical documentation, risk management files, performance evaluation evidence and submission materials. Manage global registrations, regulatory submissions and interactions with authorities, authorised representatives, distributors, and external partners. Oversee post‑market surveillance, vigilance reporting, and safety officer responsibilities. Ensure regulatory compliance of product labelling, promotional materials and commercial documentation. Maintain accurate regulatory records, documentation systems and databases. Provide expert interpretation of global regulations and support conformity to evolving standards. Contribute to leadership, training and development within the RA team. Act as the Person Responsible for Regulatory Compliance (PRRC) under EU IVDR. Essential Criteria Degree‑level education or equivalent in a life science or related discipline. >5 years of experience in IVD and/or medical device regulation (preferably EU‑related). Recognisable qualification in Regulatory Affairs (e.g. RAPS, TOPRA) and evidence of ongoing CPD. Strong experience working within an ISO 13485 Quality Management System. Ability to independently manage multiple projects, department initiatives and day‑to‑day regulatory tasks. Desirable Criteria Expertise in IVD regulatory frameworks, including 21 CFR Part 820 (QSR/QMSR). Experience in post‑market surveillance, vigilance and product recall activities. Proven experience interacting with competent authorities, global regulators and notified bodies. Why join us? High‑impact strategic role with global regulatory responsibility. Opportunity to influence product development and organisational compliance. Supportive, collaborative working environment. Competitive salary and benefits package. #J-18808-Ljbffr
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Global Regulatory Affairs Lead
Vor 7 Tagen
Town Of Cambridge, Österreich Russell Taylor Group VollzeitA leading healthcare company is seeking an experienced Regulatory Affairs Manager to oversee global regulatory activities. This hybrid position responsibilities include leading regulatory strategies, ensuring product compliance, and managing submissions. The ideal candidate will have over 5 years in IVD or medical device regulation and a degree in a life...
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Regulatory Affairs Associate
vor 3 Wochen
City of Brisbane, Österreich DTS Regulatory Consultants VollzeitA leading regulatory consultancy firm based in Brisbane is seeking an Associate Scientific Regulatory Consultant to support regulatory affairs related to agricultural products. The ideal candidate will have a degree in a scientific discipline and at least 3 years of relevant experience. This is a full-time position with a four-day work week, located in...
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Regulatory Affairs Specialist
vor 2 Wochen
Council of the City of Sydney, Österreich i-Pharm Consulting VollzeitRegulatory Affairs Specialist – 12‑Month Contract Global Medical Devices Leader | APAC Focus | Sydney Step into a pivotal Regulatory Affairs role with a global, award‑winning medical devices company whose technologies are used by healthcare professionals in over 160 countries. The Opportunity As Regulatory Affairs Specialist – you will be part of the...
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Regulatory Affairs Specialist
Vor 7 Tagen
Council of the City of Sydney, Österreich i-Pharm Consulting VollzeitRegulatory Affairs Specialist | 12-Month Contract Global Medical Devices Leader | APAC Focus | Sydney Step into a pivotal Regulatory Affairs role with a global, award‑winning medical devices company whose technologies are used by healthcare professionals in over 160 countries. This is a unique 12‑month contract opportunity to drive high‑impact APAC...
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Regulatory Affairs Product Manager
vor 2 Wochen
Council of the City of Sydney, Österreich Kimberly-Clark Corporation VollzeitRegulatory Affairs Product Manager page is loaded## Regulatory Affairs Product Managerlocations: Australia – North Sydneytime type: Full timeposted on: Posted Todayjob requisition id: Regulatory Affairs Product Manager## **Job Description**People have looked to **Kimberly-Clark** brands for more than 150 years and today we're proud to help over a billion...
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Manager, Regulatory Affairs, APAC
vor 3 Wochen
Council of the City of Ryde, Österreich Johnson & Johnson Innovative Medicine VollzeitJohnson & Johnson Innovative Medicine – Ryde NSW At Johnson & 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...
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Manager, Regulatory Affairs, APAC
vor 2 Wochen
Council of the City of Sydney, Österreich Johnson & Johnson Innovative Medicine VollzeitJoin to apply for the Manager, Regulatory Affairs, APAC role at Johnson & Johnson Innovative Medicine . At Johnson & 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....
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Manager, Regulatory Affairs, APAC
vor 3 Wochen
Council of the City of Sydney, Österreich Johnson & Johnson VollzeitAt Johnson & 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...
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Regulatory Affairs Product Manager
vor 2 Wochen
Council of the City of Sydney, Österreich Kimberly Clark VollzeitRegulatory Affairs Product Manager Job Description People have looked to Kimberly-Clark brands for more than 150 years and today we're proud to help over a billion people around the world cope, laugh, love and live every day. From the best nappies and baby wipes to the softest tissues, to the best supplies for business, we are constantly searching for new...
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Council of the City of Sydney, Österreich KE Select VollzeitA global leader in clinical diagnostics is looking for a Regulatory Affairs Manager in Sydney, Australia. The successful candidate will ensure regulatory compliance with TGA and other bodies, manage key relationships, and develop regulatory plans. Applicants should have over 5 years of experience in regulatory affairs and a Bachelor's Degree or higher....
