Principal Regulatory Affairs Strategist
2 months ago
Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.
Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day
Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
This role is eligible for a remote work arrangement.
The **Principal Regulatory Affairs Strategist** has responsibilities for regulatory strategy development and execution for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology environment. **You will provide oversight and lead 510k and PMA submission work and will mentor the RA organization in these key activities.** The role collaborates cross-functionally and, with internal and external business partners on new product development and strategic initiatives to lead the regulatory activities for global commercialization with focus on the US market clearance. The incumbent has the ability to innovate, communicate and execute strategic regulatory plans, drive results independently and in a matrix-team environment and is willing to solve complex problems to meet business obligations on-time.
**Major Responsibilities**
- Serve as regulatory lead for business-critical new product development projects and external partnership programs; including oversight for product lifecycle management ensuring that the state of the art requirements are maintained
- Work with regulatory agencies to establish least burdensome regulatory strategies/paths to validate desired product claims for LBS products, including 510(k), PMA and companion diagnostic submissions
- Manage schedules for regulatory submissions (for example, 510(k), PMA, preSUBs, etc.), coordinate the preparation and staging of all regulatory documentation, and actively monitor and track submissions under review
- Lead regulatory agency interactions for products under review, ensure timely responses and communications, and successfully navigate through the process to secure registrations
- Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Quality Assurance, Research & Development, Product/Program Management) to define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD and Companion Diagnostics markets.
- Maintain regulatory intelligence on US and International regulatory requirements and proactively manage impact to LBS current and future portfolio
- Actively participate in project core team meetings and drive to collaboratively achieve project goals and meet timelines
- Critically review and approve analytical and clinical study protocols and reports to assess quality, to identify gaps, and provide mitigations
- Provide periodic updates on status of projects to larger cross-functional audience and leadership
- Ensure compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect
- Mentor and coach LBS Regulatory professionals in their development
- Integrates DBS principles and practices including leading continuous improvement initiatives, solving complex problems and driving for measurable results.
**Required Skills/Experience/Education**
- Bachelor, Master or PhD degree in science or engineering with 8 years Regulatory experience in the IVD industry
- Expert in FDA and EU regulations for IVDs and/or medical devices
- Experience in support of New Product Development for high complexity products with experience supporting complex clinical trials
- Proven experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market, specifically 510(k) and PMA submissions in the USA
- Experience in the IVD, Companion Diagnostics and/or stand-alone software/digital fields preferred.
- Strong inter-personal skills and an ability to effectively communicate complex ideas and concepts to a diverse audience
Travel expectations for this role are
-
Senior Regulatory Affairs Specialist
2 months ago
York, United Kingdom VRS Recruitment Full timeAn EU wide Regulatory Affairs / coordination role at an expanding crop protection business. They have an expanding list of actives and a diverse portfolio of products including herbicides, fungicides, biostimulants and adjuvants. This role would involveregistration strategy, study placement/monitoring, coordinating external experts for technical work and...
-
Regulatory Affairs Specialist
2 months ago
York, United Kingdom Cepheid Full time**ESSENTIAL JOB RESPONSIBILITIES**: - Support the IVDR transition project - Closely collaborate with other functions to achieve the goal in the set timelines - Review project documentation, implement update of Technical Files/Technical Documentation IVDD and IVDR - Compile and make files ready for publishing and submission **TRAINING RESPONSIBILITIES:...
-
Biostimulants Regulatory Affairs Specialist
2 months ago
York, United Kingdom Yara Full timeDate posted: Feb 27, 2023- Location: York, ENG, GB Tampa, FL, US Le Havre, 76, FR Milano, Milan, IT Berlin, BE, DE Madrid, M, ES- Job Function: Strategy & Business Development- Job Type: Permanent- Job Requisition ID: 14875**Biostimulants Regulatory Affairs Specialist**: **About the Unit**: **Global innovation** Yara has a strategic agenda to support the...
-
Ecotoxicologist
5 days ago
York, United Kingdom VRS Regulatory Full timeWe are looking for an ecotoxicologist / ecotoxicology specialist to join the environmental risk assessment team of an expanding chemical regulatory science consultancy. Ideally you will have existing experience of ecotoxicology evaluation of chemical / agrochemical products and substances - this could be with a competent authority, consultancy or...
-
Senior Regulatory Affairs Specialist
2 months ago
York, United Kingdom Cepheid Full time**ESSENTIAL JOB RESPONSIBILITIES**: - Support the IVDR transition project - Closely collaborate with other functions to achieve the goal in the set timelines - Review project documentation, implement updates of Technical Files/Technical Documentation IVDD and IVDR - Compile and make files ready for publishing and submission **TRAINING RESPONSIBILITIES:...
-
Regulatory Affairs Associate
2 weeks ago
York, United Kingdom Abingdon Health Full timeAbingdon Health is a world leading developer and manufacturer of high-quality rapid tests across all industry sectors, including healthcare and COVID-19. We take projects from initial concept through to routine and large-scale manufacturing and have also developed and marketed our own labelled tests. We offer product development, regulatory support,...
-
Regulatory Efficacy Specialist
2 months ago
York, United Kingdom VRS Recruitment Full timeAn opportunity for a Regulatory Efficacy Specialist to join an expanding consultancy providing global compliance and technical support to the agchem, biocide and chemical sectors. This role will focus on supporting new and renewal submission of conventionaland biological compounds for PPPs. Working on a wide range of substances and products, you will assess...
-
Deputy Clerk
3 weeks ago
York, United Kingdom City of York Council Full time**NON CYC VACANCY** Huntington Parish Council (in the City of York) is seeking to recruit a Deputy Clerk whose role will be to assist the existing Clerk in the execution of all Council business and to meet the parish council's statutory requirements. The Deputy Clerk will also be required to deputise for the Clerk in their absence. At Huntington Parish...
-
Pesticides Operational Support Team Leader
5 days ago
York, United Kingdom Health and Safety Executive Full time**Details**: **Reference number**: - 343263**Salary**: - £27,316 - £30,344- A Civil Service Pension with an average employer contribution of 27%**Job grade**: - Executive Officer- Band 5**Contract type**: - Permanent**Business area**: - HSE - Chemical Regulations Division (CRD)**Type of role**: - Administration / Corporate Support**Working...
-
Flow Cytomerty Scientist
2 weeks ago
York, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Flow Cytometry Scientist to join a leading laboratory, specialising in clinical trials, central lab services and toxicology on a permanent basis. The Flow Cytometry Scientist will form part of the Biomarker group within Laboratory Operations performing analysis of clinical samples, working to Good Clinical Practice (GCP)...
-
Flow Cytomerty Scientist
2 weeks ago
York, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Flow Cytometry Scientist to join a leading laboratory, specialising in clinical trials, central lab services and toxicology on a permanent basis. The Flow Cytometry Scientist will form part of the Biomarker group within Laboratory Operations performing analysis of clinical samples, working to Good Clinical Practice (GCP)...
-
Flow Cytomerty Scientist
5 days ago
York, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Flow Cytometry Scientist to join a leading laboratory, specialising in clinical trials, central lab services and toxicology on a permanent basis. The Flow Cytometry Scientist will form part of the Biomarker group within Laboratory Operations performing analysis of clinical samples, working to Good Clinical Practice (GCP)...
-
Agricultural Supply Chain Adjudicator
2 weeks ago
York, United Kingdom GatenbySanderson Full time**Agricultural Supply Chain Adjudicator**: **Department for Environment, Food and Rural Affairs**: **York, Bristol, Newcastle, or London, with flexible and part-time working available.**: - Location York, Bristol, Newcastle, or London, with flexible and part-time working available. - Sector Regulation & Professional Standards - Client Department for...
-
Personnel Security Advisor
1 week ago
York, United Kingdom Department for Environment, Food and Rural Affairs (Defra) Full timeDefra group Security function is recruiting a Personal Security Advisor who will report to the Head of Physical & Personnel Security. Defra group Security enable Defra group to make informed, balanced decisions on security risks to achieve our environmental outcomes whilst keeping our assets secure. The Personnel Security Team aims to manage and minimise...
-
Flow Cytomerty Scientist
6 days ago
York, North Yorkshire, United Kingdom CK Group Full timeCK Group are recruiting for a Flow Cytometry Scientist to join a leading laboratory, specialising in clinical trials, central lab services and toxicology on a permanent basis. The Flow Cytometry Scientist will form part of the Biomarker group within Laboratory Operations performing analysis of clinical samples, working to Good Clinical Practice (GCP)...
-
Flow Cytomerty Scientist
2 weeks ago
York, United Kingdom CK Group Full timeCK Group are recruiting for a Flow Cytometry Scientist to join a leading laboratory, specialising in clinical trials, central lab services and toxicology on a permanent basis. The Flow Cytometry Scientist will form part of the Biomarker group within Laboratory Operations performing analysis of clinical samples, working to Good Clinical Practice (GCP)...
-
Associate Director of Quality Assurance and
2 months ago
York, North Yorkshire, United Kingdom Pivot Search Full timeAssociate Director Quality Assurance The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations. This leader collaborates closely with the Clinical Trials...
-
Associate Director, Quality Assurance
3 weeks ago
York, United Kingdom ACM Global Laboratories, Inc. Full timeAssociate Director, Quality Assurance page is loaded Associate Director, Quality Assurance Apply locations ACM - York Building 23 time type Full time posted on Posted 3 Days Ago job requisition id REQ_195463 HOW WE CARE FOR YOU: At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster...
-
Administrator
2 months ago
University of York, United Kingdom University of York Full time**Department**: Student Administration and Academic Affairs (SAAA) works to enable an excellent experience for students during their time at the University of York, providing information, advice, guidance and support to students from enrolment through to graduation. SAAA also provides advice and guidance to colleagues across the University who rely on its...
-
Administration Officer
3 days ago
University of York, United Kingdom University of York Full time**Department**: Student Administration and Academic Affairs (SAAA) works to enable an excellent experience for students during their time at the University of York, providing information, advice, guidance and support to students from enrolment through to graduation. SAAA also provides advice and guidance to colleagues across the University who rely on its...