Regulatory Affairs Specialist

4 days ago

England, United Kingdom Medella Life Full time

Job Title: Regulatory Affairs Specialist (12-month Contract)


Location: Hybrid - Cambridge, UK


Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a focus on In Vitro Diagnostics (IVD). The position will be based in our Cambridge office, offering a hybrid work arrangement.


Key Responsibilities:


Regulatory Compliance:

  • Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a specific emphasis on IVDs.
  • Monitor and interpret changes in regulations to ensure the company's products meet all requirements.


Submission Management:

  • Prepare and submit regulatory documents, including 510(k) submissions, CE Mark applications, and other regulatory filings.
  • Collaborate with cross-functional teams to gather necessary information for regulatory submissions.


Quality System Support:

  • Contribute to the development and maintenance of the company's quality management system to ensure ongoing compliance.
  • Participate in internal and external audits related to regulatory affairs.


Product Lifecycle Management:

  • Support regulatory aspects of product development from concept through commercialisation.
  • Provide regulatory input to product development teams and ensure compliance throughout the product lifecycle.


Communication and Collaboration:

  • Liaise with regulatory authorities, notified bodies, and other relevant stakeholders.
  • Collaborate with internal teams, including R&D, Quality Assurance, and Marketing, to achieve regulatory goals.


Qualifications:

  • Bachelor's degree in a relevant scientific or engineering discipline.
  • Proven experience in Regulatory Affairs within the Medical Device sector, with specific exposure to In Vitro Diagnostics (IVDs).
  • Strong understanding of regulatory requirements, including FDA regulations, EU MDR, and other global regulatory frameworks.
  • Experience with preparing and submitting regulatory documents and interacting with regulatory agencies.
  • Excellent communication and interpersonal skills.


Desirable Skills:

  • Familiarity with international regulatory requirements for medical devices.
  • Previous experience in a hybrid work environment.
  • Certifications in Regulatory Affairs would be an advantage.


Duration and Compensation: This is a contract position with a competitive rate with experience and qualifications. The selected candidate may have the opportunity for extension or permanent employment based on performance and company needs.

We look forward to receiving applications from qualified individuals who are passionate about maintaining high-quality standards and driving continuous improvement within our organisation.

  • Regulatory Affairs Specialist

    1 week ago

    England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract) Location: Hybrid - Cambridge, UK Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a...

  • Regulatory Affairs Specialist

    1 week ago

    England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract) Location: Hybrid - Cambridge, UK Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a...

  • Regulatory Affairs Specialist

    4 days ago

    England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract) Location: Hybrid - Cambridge, UK Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a...

  • Regulatory Specialist and Senior Specialist

    1 week ago

    England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract) Location: Hybrid - Cambridge, UK Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a...

  • Regulatory Specialist and Senior Specialist

    2 days ago

    England, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract) Location: Hybrid - Cambridge, UK Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a...

  • Senior Manager/Director of Regulatory Affairs

    6 days ago

    England, United Kingdom Community Integrated Care Full time

    REGISTRATION, COMPLIANCE AND COMPLAINTS EXPERIENCE FOR A CARE REGULATOR ? We are Community Integrated Care a national Health and Social Care Organisation supporting people with autism, learning disabilities and mental health issues and we are looking to recruit an experienced Regulatory Compliance Manager on a full time permanent basis based anywhere in the...

  • Senior Manager/Director of Regulatory Affairs

    6 days ago

    England, United Kingdom Community Integrated Care Full time

    REGISTRATION, COMPLIANCE AND COMPLAINTS EXPERIENCE FOR A CARE REGULATOR ? We are Community Integrated Care a national Health and Social Care Organisation supporting people with autism, learning disabilities and mental health issues and we are looking to recruit an experienced Regulatory Compliance Manager on a full time permanent basis based anywhere in the...

  • Commercial Property

    1 week ago

    England, United Kingdom Actis Recruitment Full time

    Commercial Property & Agricultural Affairs Solicitor Salary: £40,000 - £50,000 Ref: 56892/2TML Location: Cheshire Areas of Law: Agricultural, Commercial Property/Real Estate Job Type: Permanent Level: 4-6 years qualified, 2-4 years qualified Sector: Private practice This Cheshire based law firm enjoys an outstanding reputation for quality of...

  • Health & Safety Regulatory Solicitor

    6 days ago

    England, United Kingdom William James Recruitment Full time

    The RoleThis is a superb opportunity to join an established law firm that offers specialist quality legal advice to both businesses and individuals.The firm is recognised for its outstanding client care and high-quality Crime and Regulatory work, among other highly regarded practice areas.Due to the development and expansion of the firm, they are now seeking...

  • Health & Safety Regulatory Solicitor

    6 days ago

    England, United Kingdom William James Recruitment Full time

    The RoleThis is a superb opportunity to join an established law firm that offers specialist quality legal advice to both businesses and individuals.The firm is recognised for its outstanding client care and high-quality Crime and Regulatory work, among other highly regarded practice areas.Due to the development and expansion of the firm, they are now seeking...

  • Sustainable Procurement Specialist

    1 week ago

    England, United Kingdom Urenco Global Full time

    Help us to make a world of difference Urenco is a global leader in the production of low carbon energy. We work at the cutting edge of the transition to a sustainable, net zero world. We’re looking for a Sustainability Procurement Specialist. Based at our Capenhurst location, you’ll be responsible for delivering and implementing sustainable...

  • Sustainable Procurement Specialist

    4 days ago

    England, United Kingdom Urenco Global Full time

    Help us to make a world of differenceUrenco is a global leader in the production of low carbon energy. We work at the cutting edge of the transition to a sustainable, net zero world.We’re looking for a Sustainability Procurement Specialist. Based at our Capenhurst location, you’ll be responsible for delivering and implementing sustainable procurement...

  • Sustainable Procurement Specialist

    4 days ago

    England, United Kingdom Urenco Global Full time

    Help us to make a world of difference Urenco is a global leader in the production of low carbon energy. We work at the cutting edge of the transition to a sustainable, net zero world. We’re looking for a Sustainability Procurement Specialist. Based at our Capenhurst location, you’ll be responsible for delivering and implementing sustainable procurement...

  • Sustainable Procurement Specialist

    4 days ago

    England, United Kingdom Urenco Global Full time

    Help us to make a world of differenceUrenco is a global leader in the production of low carbon energy. We work at the cutting edge of the transition to a sustainable, net zero world.We’re looking for a Sustainability Procurement Specialist. Based at our Capenhurst location, you’ll be responsible for delivering and implementing sustainable procurement...

  • Sustainable Procurement Specialist

    14 hours ago

    England, United Kingdom Urenco Global Full time

    Help us to make a world of difference Urenco is a global leader in the production of low carbon energy. We work at the cutting edge of the transition to a sustainable, net zero world. We’re looking for a Sustainability Procurement Specialist. Based at our Capenhurst location, you’ll be responsible for delivering and implementing sustainable...

  • Integrations Specialist

    1 week ago

    England, United Kingdom iO Associates - UKEU Full time

    Integrations Specialist Midlands | Hybrid Working £400/day (outside IR35)6 month contract iO Associates are recruiting on behalf of our HealthTech client, a leading provider of advanced laboratory services and products with international operations. They are seeking a talented Senior Integrations Specialist to support their healthcare integration...

  • Integrations Specialist

    1 week ago

    England, United Kingdom iO Associates - UKEU Full time

    Integrations SpecialistMidlands | Hybrid Working £400/day (outside IR35) 6 month contract iO Associates are recruiting on behalf of our HealthTech client, a leading provider of advanced laboratory services and products with international operations. They are seeking a talented Senior Integrations Specialist to support their healthcare integration...

  • Integrations Specialist

    2 days ago

    England, United Kingdom iO Associates - UKEU Full time

    Integrations Specialist Midlands | Hybrid Working £400/day (outside IR35)6 month contract iO Associates are recruiting on behalf of our HealthTech client, a leading provider of advanced laboratory services and products with international operations. They are seeking a talented Senior Integrations Specialist to support their healthcare integration...

  • Integrations Specialist

    14 hours ago

    England, United Kingdom iO Associates - UKEU Full time

    Integrations Specialist Midlands | Hybrid Working £400/day (outside IR35)6 month contract iO Associates are recruiting on behalf of our HealthTech client, a leading provider of advanced laboratory services and products with international operations. They are seeking a talented Senior Integrations Specialist to support their healthcare integration...

  • Senior Medical Manager

    4 days ago

    England, United Kingdom SUN PHARMA Full time

    Job offerFor our dynamic growing, innovative Brands division in UK within an already established big generic International pharmaceutical company, we are looking for an outgoing experienced Senior Medical Affairs field professional who dares to look outside the clear-cut frames of a common big pharma job and who can operate in an autonomous entrepreneurial...