Current jobs related to Senior Regulatory Affairs Specialist - crawley west sussex - Welland Medical Ltd

  • Regulatory Affairs Manager

    2 weeks ago

    North West, United Kingdom Reed Specialist Recruitment Ltd Full time

    Regulatory Affairs Manager Job Description:Reed Specialist Recruitment Ltd are working in partnership with a global healthcare provider based in the North-West of the UK to find an experienced Regulatory Affairs Manager to lead the regulatory affairs team.Main Responsibilities:Regulatory Strategy: Develop and implement regulatory strategies to ensure...

  • Regulatory Affairs Director

    3 weeks ago

    North West, United Kingdom Reed Specialist Recruitment Ltd Full time

    Regulatory Affairs ManagerReed Specialist Recruitment Ltd is seeking an experienced Regulatory Affairs Manager to oversee and manage the regulatory affairs team for a global healthcare provider based in the North West of the UK.Main Responsibilities:Regulatory Strategy: Develop and implement regulatory strategies to ensure compliance with relevant laws and...

  • Regulatory Affair Specialist

    5 months ago

    South West London, United Kingdom Harrington Recruitment Ltd Full time

    **The Role** The Regulatory Affairs Specialist will report to the Commercial Director. This is expected to be a hybrid role, 3 days per week working from home and 2 days based South-West London. The person should be located a commutable distance to the office.. Working together with colleagues in Germany, the Regulatory Affairs Specialist will be required...

  • Regulatory Affairs Specialist

    4 weeks ago

    West Yorkshire, United Kingdom Seven Life Sciences Full time

    Job Title: Regulatory Specialist and Senior SpecialistSeven Life Sciences is seeking a highly skilled Regulatory Specialist to support our business in maintaining compliance with ISO 13485, Medical Device Directive 93/42/EEC, and Regulation (EU) 2017/745 (EU MDR).Key Responsibilities:Review, update, and create technical files for various medical...

  • Regulatory Affairs Manager

    4 weeks ago

    North West, UK, United Kingdom Reed Specialist Recruitment Ltd Full time

    Head of Regulatory Affairs (Healthcare)Location: North-West, UKFull time & permanent positionOnsite 3-4 days per weekReed Scientific are working with a global healthcare provider based in the North West of the UK, and are currently seeking an experienced Regulatory Affairs Manager to oversee and manage the regulatory affairs team.Main Responsibilities:

  • Regulatory Affairs Director

    4 weeks ago

    North West England, United Kingdom REED SPECIALIST RECRUITMENT LTD Full time

    As the Regulatory Affairs Manager, you will oversee and manage the regulatory affairs team for a global healthcare provider based in the North West of the UK. Your main responsibilities will include:Main Responsibilities:Managing the regulatory affairs teamOverseeing regulatory complianceDeveloping and implementing regulatory strategiesCollaborating with...

  • Regulatory Affairs Specialist

    1 month ago

    North West, United Kingdom Kandhu Recruitment Ltd Full time

    Regulatory Affairs Advisor OpportunityAn exciting opportunity has arisen for a German Speaking Regulatory Affairs professional to join Kandhu Recruitment Ltd, a specialist recruiter within the Food, Drink and FMCG Sector.Key Responsibilities:Review product information against regulation and customer policiesAdvise customers and their suppliers on...

  • Regulatory Affairs Specialist

    1 month ago

    North West, United Kingdom Kandhu Recruitment Ltd Full time

    Regulatory Affairs Advisor OpportunityAn exciting opportunity has arisen for a German Speaking Regulatory Affairs professional to join Kandhu Recruitment Ltd, a specialist recruiter within the Food, Drink and FMCG Sector.Key Responsibilities:Review product information against regulation and customer policiesAdvise customers and their suppliers on...

  • Regulatory Affairs Specialist

    1 month ago

    West Yorkshire, United Kingdom NHS Full time

    Regulatory Affairs Specialist OpportunityAn exciting opportunity has arisen for a skilled Regulatory Affairs Specialist to join the patient safety team at NHS, as part of the Transformation Directorate's Digital Clinical Informatics (DCI) team.The role will support the quality and regulatory team in implementing and maintaining NHS-England's quality...

  • Regulatory Affairs Specialist

    1 month ago

    West Yorkshire, United Kingdom NHS Full time

    Regulatory Affairs Specialist OpportunityAn exciting opportunity has arisen for a skilled Regulatory Affairs Specialist to join the patient safety team at NHS, as part of the Transformation Directorate's Digital Clinical Informatics (DCI) team.The role will support the quality and regulatory team in implementing and maintaining NHS-England's quality...

  • Regulatory Affairs Specialist

    4 weeks ago

    West of England, United Kingdom Yolk Recruitment Full time

    Regulatory Affairs Specialist (Contract)Yolk Recruitment is partnering with a growing medical device manufacturer to fill a new opportunity for a Regulatory contractor.This part-time role, working 2-3 days a week, requires supporting worldwide regulatory submissions, reviewing and managing standards databases, and advising on implementing changes to...

  • Chemical Regulatory Affairs Specialist

    4 weeks ago

    West Yorkshire, United Kingdom BCL Legal Full time

    Exciting Opportunity for a Regulatory Affairs SpecialistAn exceptional chance has arisen for a skilled Regulatory Affairs Specialist to join BCL Legal's market-leading team in Leeds. You will collaborate closely with experienced Partners, developing your expertise in a top-ranked practice.The OpportunityBCL Legal, a UK Top 100 commercial law firm, attracts...

  • Chemical Regulatory Affairs Specialist

    4 weeks ago

    West Yorkshire, United Kingdom BCL Legal Full time

    Exciting Opportunity for a Regulatory Affairs SpecialistAn exceptional chance has arisen for a skilled Regulatory Affairs Specialist to join BCL Legal's market-leading team in Leeds. You will collaborate closely with experienced Partners, developing your expertise in a top-ranked practice.The OpportunityBCL Legal, a UK Top 100 commercial law firm, attracts...

  • Regulatory Affairs Specialist

    4 weeks ago

    West Yorkshire, United Kingdom Quanta Consultancy Services Ltd Full time

    Senior Regulatory Manager - PharmaceuticalsQuanta Consultancy Services Ltd is seeking a highly skilled Senior Regulatory Manager to join our team. As a leader in the pharmaceutical industry, we are committed to delivering innovative solutions that meet the needs of our clients.The successful candidate will be responsible for developing and implementing...

  • Regulatory Affairs Director

    3 weeks ago

    North West, United Kingdom Reed Engineering Full time

    Job Title: Regulatory Affairs DirectorJob Summary:Reed Scientific is seeking an experienced Regulatory Affairs Director to oversee and manage the regulatory affairs team for a global healthcare provider based in the North West of the UK. The successful candidate will be responsible for developing and implementing regulatory strategies aligned with the...

  • Regulatory Affairs Specialist

    4 weeks ago

    West Yorkshire, United Kingdom NHS Full time

    Chemical Regulatory Affairs SpecialistAn exciting opportunity has arisen for a skilled regulatory specialist to join the patient safety team as part of the Transformation Directorate's Digital Clinical Informatics (DCI) team.The role supports the quality and regulatory team in implementing and maintaining NHS-England's quality management system in compliance...

  • Regulatory Affairs Director

    3 weeks ago

    Crawley, United Kingdom SP Global Consulting LTD Full time

    Job Title: Regulatory Affairs DirectorAbout the Role:SP Global Consulting LTD is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our organization, you will play a critical role in shaping our product portfolio and ensuring compliance with all relevant regulations across multiple geographies.Key Responsibilities:•...

  • Regulatory Affairs and Quality Lead

    4 weeks ago

    Crawley, West Sussex, United Kingdom Manor Royal Business District Full time

    Are you a seasoned professional with a passion for regulatory affairs and quality management? We're seeking a highly skilled Regulatory Affairs and Quality Lead to join our team in the European region.This exciting role involves overseeing and managing functions that support departmental initiatives and directives. You will be responsible for setting...

  • Regulatory Affairs and Quality Lead

    4 weeks ago

    Crawley, West Sussex, United Kingdom Elekta AB Full time

    Job Title: Regulatory Affairs and Quality LeadJob Summary:The Regulatory Affairs and Quality Lead for Region Europe is responsible for overseeing and managing functions that support departmental initiatives and directives. This role involves setting priorities, monitoring, and reporting on budget, planning, logistics, and acting as a regional coordinator for...

  • Regulatory Affairs Manager

    4 weeks ago

    West Yorkshire, United Kingdom Quanta Consultancy Services Ltd Full time

    Senior Regulatory Manager - PharmaceuticalsQuanta Consultancy Services Ltd is seeking a highly skilled Senior Regulatory Manager to join our team. As a leader in the pharmaceutical industry, we are committed to delivering innovative solutions that meet the needs of our clients.Key Responsibilities:Develop and implement country-specific regulatory strategies...

Senior Regulatory Affairs Specialist

2 months ago

crawley west sussex, United Kingdom Welland Medical Ltd Full time

About Us:


Welland Medical is the part of Clinimed Holdings Limited group, a leading name in Healthcare and Medical Equipment industry. Clinimed Holdings Limited is a group of companies founded in 1982 following the acquisition and formation of number of additional companies within the group.


Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world-class, ground-breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety.


We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open communication. Our employees are passionate, driven, and committed to delivering the best possible results for our clients.


If you have passion for learning and want to build a career with a company that values its employees and is dedicated to making a positive impact in the world, we encourage you to apply.


Benefits:


  • Contributory Pension Scheme (4% Employee and 5% Employer Contribution, increasing to 10% with service)
  • Medical Cash Back Plan
  • Life Assurance (4 x Annual Gross)
  • Annual Performance Bonus
  • Annual Pay Review
  • Cycle to Work Scheme
  • Employee Referral Scheme
  • Free Yearly Flu Vaccination
  • Discounts on Selected Products and Services
  • Employee Assistance Programme – Health and Wellbeing
  • Annual Leaves - 25 Days Per Year Rising to 27 Days After 5 Years Service In Addition to Bank Holidays and An Extra Company Day


About Job:


As a Senior Regulatory Affairs (RA) Specialist, you will be pivotal in supporting the business by developing regulatory strategies for new product development and registrations. You will manage the upkeep of all regulatory documentation and ensure that regulatory and standard changes are monitored and implemented as needed. Additionally, you will step in for the QARA Manager on all RA-related matters when required.


Main Duties & Responsibilities:


  • Lead a regulatory team of two, ensuring compliance with all relevant regulations and standards across the business.
  • Collaborate with regulatory authorities to achieve successful product registrations.
  • Develop and implement regulatory strategies for New Product Development (NPD) projects, from inception through Post-Market Surveillance, to ensure ongoing compliance and support product launches.
  • Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
  • Provide regulatory support for sales and commercial activities, addressing customer and market authority inquiries and managing expectations.
  • Lead interactions with Notified Bodies on regulatory affairs (RA) matters.
  • Support all communications with regulatory authorities.
  • Lead regulatory transition projects and other significant regulatory initiatives.
  • Lead submission strategies for NPD projects and offer guidance on R&D product development.
  • Oversee regulatory decisions related to change control, assessing implications, approving or rejecting as appropriate, and maintaining accurate records of actions taken.
  • Support Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification, ensuring regulatory compliance across the organization.
  • Participate in auditing processes, providing regulatory guidance, and engaging in Notified Body audits.
  • Support vigilance reporting and Field Safety Corrective Actions (FSCA), liaising with regulatory authorities as needed.
  • Monitor and review changes in regulations and standards, assessing their impact on the business.
  • Ensure that Instructions for Use (IFUs), labelling, marketing materials, and technical documentation comply with relevant regulations and standards.
  • Create and maintain procedures to ensure ongoing regulatory compliance.
  • Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
  • Manage, support, and mentor the RA team.


About You:


An ideal candidate for this position will have the following experience, skills, and attributes. Please note that these competencies are not ranked in order of priority. Following criteria will be used in selecting a candidate.


Essential:


  • Bachelor’s degree (or equivalent) in a scientific, engineering, legal, or regulatory discipline.
  • Previous experience in a Quality Assurance or Regulatory Affairs role within a medical device manufacturer, Notified Body, consultancy, or regulatory agency.
  • Demonstrable experience working with EU MDD/MDR Class I and/or Class II devices.
  • Proven experience with medical device technical files and EU MDD/MDR requirements.
  • In-depth understanding of the relationship between international standards and regulatory requirements, including the role of harmonized standards.
  • Comprehensive knowledge of EN ISO 13485.
  • Current specialist knowledge of medical device regulatory requirements in the EU and UK.
  • Familiarity with EN ISO 14971.
  • Experience working within a Quality Management System certified to EN ISO 13485.
  • Strong leadership skills with the ability to independently take initiative and complete tasks.
  • Exceptional attention to detail, with a clear understanding of the broader implications of actions and decisions.
  • Excellent written and verbal communication skills, effective across all levels of the organization and with external contacts.
  • Ability to manage competing priorities and workloads to meet deadlines.


Desirable:


  • Additional qualifications in the field of medical device regulatory affairs.
  • Demonstrable experience as part of a project team implementing significant regulatory transitions (e.g., EU MDD to EU MDR).
  • Experience working with non-EU medical device regulations.
  • Detailed knowledge of EN ISO 15223-1.
  • Project management experience.
  • Experience working within EN ISO 14971, EN ISO 15223, and EN ISO 20417.