Regulatory Affairs and Quality Assurance Specialist
Experience with Quality Control and Quality Assurance are a minimum requirement irrespective of the field of employment.
We appreciate that Medical devices (MDD/MDR) represent a niche industry in Regulatory affairs and so we encourage applicants with a background in the food industry, automotive industry or any other field which is highly regulated.
The ideal candidate is affiliated to TOPRA The organisation for professionals in Regulatory affairs.
A successful candidate interested in pursuing a qualification with TOPRA would receive our support and sponsorship that would be tied in to the contract of employment on the understanding that certain expectations would be met.
A Biomedical sciences Batchelors degree would put any candidate in an excellent position in terms of their baseline ability to process relevant information. This is desired but not essential.
As an RAQA Specialist you will be asked to follow the regulatory strategy for assigned corporate projects while writing, filing, and obtaining approvals for EU and international regulatory submissions.
Roles and Responsibilities
Keep up-to-date and comply with the regulatory requirements and international standards within the region (ISO 13485).
- Represent the objectives of Regulatory Affairs Department on behalf of the company.
- Interpret general business objectives and effectively report information to senior management and relevant departments.
- Review and approve product labelling. Initiate IFUs and other required product labelling in line with relevant EU & international requirements.
- Supports “virtual manufacturer” (Own Brand) customers and liaises with EU Competent Authorities and other Ministries of Health as necessary.
- In addition to the required technical documentation, supplies samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for product registrations.
- Undertakes other administrative tasks to support CE marking and regional registrations.
- Demonstrates professional behaviours to internal and external business associates that reflect positively on Unisurge International Ltd., the individual needs to convey a trustworthy, credible, and reliable image at all times.
- Acts as a resource to the regions on quality issues and proposes changes to minimise risks, enhance quality, reliability, safety and productivity.
Key knowledge and skills:
- A broad knowledge of regulatory affairs and CE certification.
- Good organisational skills
- Impeccable time management skills
- Self sufficient in order to complete tasks to deadlines with minimal supervision.
- Excellent attention to detail
- Someone who is strong individually and a good team player.
We are looking for a candidate with:
Good understanding of ISO 13485 requirements and EU Medical Device Regulations (MDD & MDR).
- Ability to read and understand technical material.
- Excellent written and verbal communication skills.
- Computer literate, with intermediate skills in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Microsoft Dynamics.
- Experienced at reviewing and approving product labelling.
- Flexible and able to self-manage multiple priorities.
- Able to work effectively in multinational/multicultural environments.
- Flexibility to work across the UK sites.
- Full, current driving licence.
We are looking for someone with
- relevant medical device regulatory submission ability
- Technical File writing experience,
- Experience representing regulatory affairs on cross-functional project teams.
- Auditing experience is desirable although not essential
- A Bachelor’s of science degree or equivalent qualification in a technical discipline
- A working knowledge of Medical Device Regulations is required.
Salary: £35-50,000 (negotiable based on relevant experience and qualifications). We operate a profit sharing scheme.
Closing date: 01/07/2020
Unisurge International Ltd is the leading manufacturer of single use sterile medical devices and custom procedure packs. Our range of bespoke single use products is both cost effective and patient specific.
This is a unique and exciting opportunity for a procurement leader to be a key influencer to overall business strategy, utilising specifically your industry knowledge, your procurement skills and innovative ideas to the business. Alongside the Directors and Senior Management team, you will be an integral part of the rapid growth within the business.
- Develop and manage the procurement department including setting targets and monitoring performance.
- Promote the effective management of suppliers to sustain value throughout the life of the contract.
- Improve / implement processes and systems for effective procurement across the Company.
- Provide specialist advice, guidance and service on leading practice procurement to all marketing activities; lead the Company in identification, assessment and management of potential risks associate with different sourcing strategies; provide insight through the analysis of spend, supply markets and savings.
- Develop and maintain a robust framework for Supplier Management.
- Enhance relationships to ensure effective execution of strategies and drive cost savings.
- Provide regular reporting to the Senior Team and Directors.
Skills and Qualifications:
- Degree qualified in an appropriate discipline / MCIPS
- A proven record in delivering cost savings without sacrificing Quality.
- A healthcare background would be beneficial
- Familiar with tracking and setting Purchasing / Supply Chain KPI’s.
- Familiar with tightly regulated processes and procedures.
- A strong Manager of people who has proven experience in managing change.
- Procurement and supplier management experience gained at senior level.
- Comfortable with fast changing priorities.
- Strong attention to detail.
- Experience of Global Sourcing
- Highly developed business acumen and negotiation/influencing skills.
- Good communication and interpersonal skills.
- Focuses on making change happen and has the influencing skills to do this.
- Tenacious in achieving results, keeps going when presented with setbacks.
- Able to challenge existing purchasing practices in a positive way.
– We offer a competitive salary
– 25 days holiday plus 8 Bank/Public Holiday days
— Life assurance and pension scheme
Applications from previous candidates will not be considered
Unisurge International Ltd is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.
Job Type: Permanent
- Purchasing: 5 years in a Senior position
Cleanroom operative tasks involve
Assembly of packs, sealing, counting components ensuring accuracy
Packing items in to boxes
Breakdown of products
Picking of raw materials
Closing date: 01/04/2021
Putting away finished goods
Picking finished goods for dispatch
Forklift driving (VNA, flexi, counter balance)
Closing date: 01/04/2021
Driver - HGV (Class1 and 2), Van driver Zero hours contract
To perform multiple duties associated with the delivery of goods to customers. Accountable for maintaining cGMP and EHS compliance at all times.
Key responsibilities and accountabilities:
- To deliver goods to customers in a timely manner.
- To follow all local rules for deliveries at customer locations.
- To get all paperwork signed by customers upon receipt of goods.
- Hand in all paperwork to office at the end of each day.
- Inspect the vehicle daily prior to leaving site and record all information on driver vehicle check and defect report form.
- Carry out basic maintenance of the vehicle and to keep in a clean condition.
- Record any defects on the form provided and inform office.
- Ensure that all quality regulations and requirements for the operation of vehicle are maintained at all times.
- To download Digi tacho card every Friday after last delivery.
- To deliver services effectively, a degree of flexibility is needed, and the post holder may be required to perform work not specifically referred to above.
- Accountable to: Warehouse Supervisor and Operations/Site Manager
- Responsible for: Vehicle
- Internal: Work closely with team members within the warehouse function
- External: Work closely with customers at delivery points
Education & Experience:
- Educated to a minimum GCSE Grade C or above in English and Mathematics
- Previous experience within a warehouse/driving environment desirable
- Awareness of EHS legislation
- Clean driving license Desirable
- Class 2 licence, Digi tacho card, CPC essential
- Van drivers need to hold relevant UK licence, up to 7.5 tonnes (must have passed the drivers test prior to 1994 to be eligible to drive 7.5 tonnes vehicle on basic UK licence)
Skills & Attributes:
- Ability to prioritize own workload and able to work on own initiative at times.
- Proactive in supporting the needs of the business with respect to quality and EHS systems.
We are looking for drivers to cover our regular team for holidays and sickness. Drivers need to be available at short notice to cover for variable lengths of time. Drivers need to be flexible in their working patterns.
Salary is negotiable based on experience and availability.