Being a Regulatory Affairs Specialist in UK is a great way to build a career making sure goods meet industry standards. Depending on the employer, these full-time jobs can be on-site or partly remote. The salary is around £39,000 per year, which is a good rate. Employers usually look for people who have experience in the related field, know how to follow the rules, and pay close attention to details.
This job is great for people who like working with rules, helping get products approved, and making a real difference in fields like consumer goods, medical devices, and pharmaceuticals. Having both technical knowledge and strategic impact in your job is a rewarding combination.
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Details of Regulatory Affairs Specialist Jobs in UK:
- Company: JFA Medical Ltd
- Job Type: Full Time
- Location: Manchester, United Kingdom
- Salary: 39,000.00 £ / Year
Key Responsibilities:
Technical Documentation:
- Ensure that all new medical products are accurately documented and that they comply with pertinent regulations by creating and maintaining comprehensive technical files.
- Conduct routine updates and reviews of technical documentation to ensure that it accurately reflects any modifications to regulatory requirements or product specifications.
Compliance and Quality Control:
- Monitor and guarantee that the product adheres to all pertinent medical device regulations and standards, including those established by the MHRA, Trading Standards, and other relevant authorities.
- Perform quality control assessments at different stages of the product lifecycle, such as pre-order, post-production, and periodic QC evaluations.
- Coordinate and supervise third-party product testing as required to guarantee safety and compliance.
Post-Market Surveillance:
- Execute and supervise post-market surveillance initiatives to evaluate the safety and functionality of products.
- Identify trends and areas for improvement by collecting, analyzing, and reporting on data from post-market surveillance activities.
Regulatory Registrations:
- Ensure that all products’ EUDAMED registrations are maintained and updated in a timely manner, with precise entries.
- Collaborate with regulatory authorities to guarantee that all products satisfy the registration criteria.
Product Artwork Compliance:
- Evaluate and authorize product artwork to guarantee that it adheres to all regulatory and compliance requirements.
- Work in conjunction with the marketing and design teams to guarantee that all product packaging and labeling are in compliance.
Supplier and Quality Management:
- Establish and execute comprehensive audit protocols for manufacturing partners and suppliers.
- Develop and supervise action plans with suppliers to resolve quality control concerns and guarantee ongoing enhancements.
- Collaborate with suppliers to guarantee that the quality standards agreed upon are followed.
- Maintain compliance by conducting internal audits and ensuring that one is well-versed in the ISO9001 standards.
Regulatory Affairs and Documentation:
- Analyze legal and scientific documents to guarantee product compliance.
- Stay informed about the latest developments in regulatory legislation and guidelines.
- Examine intricate data to guarantee product compliance.
- Acquire marketing authorizations, including trademarks, on a global scale.
- Define the specifications for packaging, storage, and labeling.
- Collaborate and negotiate with regulatory authorities.
- Compose product information leaflets and labels that are both user-friendly and explicit.
- Produce comprehensive product information leaflets.
Travel Requirements:
- Despite being situated in our Manchester office, it will be necessary to make weekly journeys to Blackpool, where our warehouse is located, for a period of one to two days per week, contingent upon the specific needs.
- A full driving license and a vehicle are necessary; mileage reimbursement will be provided.
Top Types of Regulatory Affairs Specialist Jobs in UK:
Clinical Trials Regulatory Affairs Specialist Jobs in UK:
Clinical Trials Regulatory Affairs Specialists make sure that clinical studies follow the rules and that trials follow UK and EU rules. Pay ranges from £39,000 to £55,000 a year, based on experience and the size of the company. Most employers want you to have worked in clinical trials or regulatory affairs for two to five years and know the GCP (Good Clinical Practice) standards. Some of their main duties are to make regulatory submissions, talk to ethics groups, and make sure that rules are followed during the whole trial process.
Pharmaceutical Regulatory Affairs Specialist Jobs in UK:
Pharmaceutical Regulatory Affairs Specialists make sure that drugs are safe from the time they are developed until they are approved for sale. Pay ranges from £40,000 to £60,000 a year, with better pay for more senior jobs. Most of the time, candidates need to have worked in pharmaceutical regulatory issues for three to six years and have a good understanding of MHRA and EMA rules. Every day, they have to put together dossiers, keep regulatory documents up to date, and help with product license applications.
Medical Device Regulatory Affairs Specialist Jobs in UK:
In the UK, the medical gadget industry needs experts to make sure that products are safe. Regulatory Affairs for Medical Devices The salary range for specialists is £42,000 to £65,000 a year, based on their experience and credentials. Employers want candidates with 3–5 years of experience in regulations and understanding of ISO 13485 and MDR regulations. As part of their job, they have to put together technical files, communicate with informed bodies, and help register products.
Biotechnology Regulatory Affairs Specialist Jobs in UK:
Biotechnology Regulatory Affairs Specialists work on new biotech goods and make sure that rules for biologics, vaccines, and advanced therapies are followed. Most salaries are between £45,000 and £70,000 a year. Most of the time, applicants need to have a good scientific background and 3–7 years of experience in biotech regulatory affairs. Planning a regulatory strategy, managing submissions, and talking to regulatory authorities are some of the most important jobs.
Benefits of Regulatory Affairs Specialist Jobs in UK:
- Job Security and Demand: The necessity of adhering to government regulations in a variety of industries has resulted in a high demand for Regulatory Affairs Specialists. This guarantees employment security and a plethora of opportunities for professional development.
- Competitive Salaries: Regulatory Affairs Specialists frequently receive competitive salaries, with the potential for increased earnings as they gain experience and specialize in specific regulatory areas or industries.
- Diverse Career Opportunities: Regulatory affairs professionals have the opportunity to work in a variety of sectors, such as pharmaceuticals, medical devices, biotechnology, cosmetics, food, and chemicals, which offers a diverse array of career opportunities.
- Professional Development: Regulatory Affairs Specialists must remain informed about the most recent regulations, guidelines, and industry standards in order to remain up-to-date with the constantly changing regulatory landscape. Professional growth and development are promoted by this ongoing learning.
- Cross-Functional Experience: Regulatory Affairs Specialists frequently collaborate with other departments, including research and development, quality assurance, manufacturing, and marketing, providing them with valuable cross-functional experience and insights into various aspects of the business.
- Global Opportunities: Regulatory Affairs Specialists who possess a comprehensive understanding of international regulations and guidelines have the opportunity to collaborate with global corporations or in various countries, thereby expanding their career prospects and providing international exposure.
- Regulatory Affairs: Influence on Public Health and Safety Specialists are essential in guaranteeing that products adhere to quality, efficacy, and safety standards. This obligation offers a sense of satisfaction, as it is recognized that their efforts contribute to the preservation of public health and safety.
- Intellectual Challenges: The position entails the interpretation and application of intricate regulations, guidelines, and standards, providing intellectual stimulation and stimulating work for individuals who appreciate problem-solving and analytical tasks.
- Career Advancement: Regulatory Affairs Specialists can progress to senior positions, such as Regulatory Affairs Manager, Director, or Vice President of Regulatory Affairs, by gaining experience. In these positions, they frequently manage strategic regulatory activities and lead teams.
- Networking Opportunities: Regulatory Affairs Specialists frequently engage with regulatory agencies, industry professionals, and stakeholders, thereby establishing a strong professional network that can be advantageous for the exchange of knowledge and the advancement of their careers.
Qualifications:
- A STEM degree with a research Master’s or PhD from a Russell Group university or an overseas equivalent is preferred.
- Indian undergraduate degrees must have been earned from an Indian Institute of Technology.
- I have exceptional documentation and organizational abilities.
- Proven capacity for problem-solving and analysis.
- Capacity to operate in a fast-paced environment both independently and collaboratively.
- A dedication to excellence and an extraordinary attention to detail.
- Proficient in both written and verbal communication
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Preferred Qualifications:
- Prior experience in regulatory affairs, quality control, or compliance within the medical device sector is advantageous; however, it is not mandatory.
What We Offer:
- Opportunities for career advancement and professional development.
- Collaborative and supportive work environment.
- The opportunity to significantly influence the quality and safety of medical products.
- Skilled Worker Visa sponsorship is available.
Frequently Asked Questions:
What does a regulatory affairs specialist do?
A Regulatory Affairs Specialist ensures that products (such as pharmaceuticals, medical devices, and cosmetics) comply with all regulations and standards set by governmental agencies. They prepare and submit regulatory documents, liaise with regulatory authorities, and keep up-to-date with changes in regulatory policies.
What is the expected salary range for a Regulatory Affairs Specialist in the UK?
Salaries can vary based on experience, location, and the specific industry. Generally, regulatory affairs specialists in the UK can expect to earn between £30,000 and £60,000 per year. Senior positions, or those with extensive experience, may earn more.
What qualifications are required to become a regulatory affairs specialist in the UK?
Typically, a bachelor’s degree in a relevant field (e.g., chemistry, pharmacy, or biological sciences) is necessary. Certifications or advanced degrees in regulatory affairs may prove advantageous. Additionally, it is crucial to possess regulatory guidelines and relevant industry experience.
