Senior Regulatory Affairs Associate
3 days ago
Senior Regulatory Affairs Associate
Medical Device
West Lothian ~ remote working available but hybrid preferred
After an incredible 12 months of working towards FDA approval and opening overseas manufacturing sites, this Scottish born medical device company are going global due to demand for their product.
As part of their growth, they are searching for an experienced regulatory professional with relevant medical device or similar experience. This role offers exposure to several regulatory areas. You will be working across global markets (US, UK, EU), and knowledge of changing EU legislation will be highly valuable.
Their Regulatory Affairs Team underpin the whole business. As manufacturers of a high risk device, it is imperative that the safety and efficacy of the product is maintained. You will be joining an existing team of excellent professionals who truly act as the glue of the business
For this reason, whilst remote working is available, some time on-site is preferred for road mapping, strategy planning and team bonding. We are happy to consider individual circumstances when discussing this.
Some preferrable areas of experience:
- Preparation of technical documentation and submission of global regulatory filings
- Familiar with MDR, PMA applications and supplements
- Regulatory strategies for new products
Requirements:
- BSc level in a technical or scientific discipline
- Experience within medical devices or diagnostics
- Knowledge of EU and international regulatory requirements
Why Apply?
- A flexible working environment
- A strong salary and bonus package
- The chance to gain or continue your career exposure to global markets and advance your experience
How to apply:
Hit the 'Easy Apply' button on this post, or email dion@entrustrs.com for a private discussion.
-
Specialist – Regulatory Affairs PPP
1 month ago
United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...
-
Specialist – Regulatory Affairs PPP
2 months ago
United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...
-
United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
-
United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
-
Senior Regulatory Affairs Associate
2 weeks ago
United Kingdom Entrust Resource Solutions Full timeSenior Regulatory Affairs AssociateMedical Device West Lothian ~ remote working available but hybrid preferred After an incredible 12 months of working towards FDA approval and opening overseas manufacturing sites, this Scottish born medical device company are going global due to demand for their product. As part of their growth, they are searching for an...
-
Senior Regulatory Affairs Associate
2 days ago
United Kingdom Entrust Resource Solutions Full timeSenior Regulatory Affairs Associate Medical Device West Lothian ~ remote working available but hybrid preferred After an incredible 12 months of working towards FDA approval and opening overseas manufacturing sites, this Scottish born medical device company are going global due to demand for their product. As part of their growth, they are searching...
-
Senior Regulatory Affairs Associate
2 weeks ago
United Kingdom Entrust Resource Solutions Full timeSenior Regulatory Affairs AssociateMedical Device West Lothian ~ remote working available but hybrid preferred After an incredible 12 months of working towards FDA approval and opening overseas manufacturing sites, this Scottish born medical device company are going global due to demand for their product. As part of their growth, they are searching for an...
-
Associate Director, Regulatory Affairs CMC
2 days ago
United Kingdom Bicycle Therapeutics Full timeAssociate Director, Regulatory Affairs CMC Full-time Contract type: Permanent Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small...
-
Senior Consultant
3 days ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including: Study monitoring Writing up study reports Risk assessments Dossier preparation Developing regulatory strategy ...
-
Senior Consultant
3 days ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including:Study monitoringWriting up study reportsRisk assessmentsDossier preparationDeveloping regulatory strategyConsortia...
-
Senior Consultant
2 days ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including: Study monitoring Writing up study reports Risk assessments Dossier preparation Developing regulatory strategy...
-
Senior Consultant
3 days ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including:Study monitoringWriting up study reportsRisk assessmentsDossier preparationDeveloping regulatory strategyConsortia...
-
Senior Consultant
2 days ago
United Kingdom VRS Regulatory Full timeAn excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including: Study monitoring Writing up study reports Risk assessments Dossier preparation Developing regulatory strategy ...
-
Associate Director, Regulatory Affairs CMC
2 days ago
United Kingdom Vertex Ventures HC Full timeCompany Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...
-
Regulatory Affairs Associate Manager
2 days ago
United Kingdom MCRA Full timeMCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to...
-
Regulatory Affairs Manager
4 weeks ago
united kingdom Reed Specialist Recruitment Ltd Full timeHead 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...
-
Regulatory Affairs Manager
1 month ago
United Kingdom Reed Specialist Recruitment Ltd Full timeHead of Regulatory Affairs (Healthcare) Location: North-West, UK Full time & permanent position Onsite 3-4 days per week Reed 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...
-
Senior Manager/Director of Regulatory Affairs
12 hours ago
United Kingdom The Advocate Group Full timeJob Title: Regulatory Affairs Manager at a Global Food Leader Are you a passionate Regulatory Affairs Professional looking to make a significant impact in a renowned global food company? Our industry-leading organisation is seeking an exceptional Regulatory Affairs Manager to drive regulatory excellence and product innovation. About the business: a...
-
Regulatory Affairs Specialist
7 days ago
United Kingdom Cure Talent Full timeCure Talent is delighted to be partnered with a global Medical Device company, specialising in emergency medical products, who due to their exceptional continued growth, have an exciting opportunity for Regulatory Affairs Specialist to join them on an initial 6-month Fixed Term Contract.This is a fully remote position and can be based anywhere in the United...
-
Head of Regulatory Affairs
3 days ago
United Kingdom CT19 Full timeHead of Regulatory Affairs CMC Location: Remote in Europe (with travel to HQ required) We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. This role is an exciting opportunity to join as Head of Regulatory Affairs CMC. Reporting directly to the Global Head of Regulatory, you will play a...