Senior Regulatory Engineer
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| Job Type | Permanent Full Time |
| Location | Lancing |
| Area | West Sussex, UK |
| Sector | Engineering |
| Salary | £50K |
| Start Date | |
| Advertiser | Nicola Francis |
| Telephone | 01342 325 316 |
| Job Ref | JB13067 |
- Description
- Lloyd Recruitment Services are pleased to be working with a leading business who are currently in search of a Senior Regulatory Engineer to join their team
The Role
We are looking for an ambitious individual to join the Quality and Regulatory team as a Senior Regulatory Engineer with the planned transfer of duties and responsibilities to eventually take over as the Quality and Regulatory Manager.
Maintaining the Company’s regulatory compliance of the product range, your main responsibilities will include:
Leadership of all regulatory related issues
Manage the establishment and maintenance of Technical Files for the Companies products and the issuing of Declarations of Conformity for those products in connection with compliance to the UKCA and EU CE marking.
Technical file review and update to meet the UK medical regulations and EU MDR requirements and then ongoing maintenance.
Take the role of Person Responsible for Regulatory Compliance
Complete Clinical Evaluations and Publication Reviews
Manage product registration, including Certificates of Free Sales and new product registrations in international markets.
Manage the transfer of new product development projects into Production, including GSPR generation, risk management, Hazard, Clinical Evaluation etc and the tracking and communication of product performance against established metrics during the post launch period.
Assist with the Post Market Surveillance process.
Assist with the Complaint and Vigilance management
You will have:
Either a degree or equivalent in Mechanical Engineering, Electrical Engineering, or similar engineering field, or in another pertinent science or technical field or,significant experience in the medical device regulatory environment. (Essential)
Ability to solve problems at an operational and strategic level, manage multiple priorities and conduct data analysis.
Knowledge of UK, European and Global Regulatory requirements. (Medical Device Regulation, MHRA, MDSAP, FDA, etc) (Essential)
Working knowledge of ISO 9001, ISO 13485, and MDD / MDR
Effective communication skills, both oral and written are required
Ability to establish and maintain an effective working relationship with subordinates, peers, and all levels of management
Experience with Class III or significant Class II medical devices
A logical and pragmatic approach coupled with the ability and tenacity to obtain information with minimal supervision is essential. Strong ability to influence and motivate people, having good business sense coupled with mature and tactful approach
Self-motivated and well organised flexible, adaptable with excellent planning and organisational skills
Also:
Experience with supervision of technical and regulatory professionals is desirable
What’s in it for you?
Salary of circa £50K DOE
25 days annual leave plus bank holidays, increasing to 30
Cycle2work scheme
Money back on everyday health costs including optical, dental and other therapies
Training and development support
Retail and health club discounts
Access to a 24-hour advice and Information line for you and your family covering legal, health and wellbeing advice
Life Assurance
Company sick pay scheme
Hybrid working
Refer a friend and earn up to £500! If you know someone who is searching for a new opportunity, recommend Lloyd Recruitment Services and you will receive a retail voucher of your choice up the value of £500. Full details can be found on our website.
Unfortunately, due to high numbers of applications, we are only able to respond to shortlisted applicants. If you have not heard from us within 5 days, please assume that you have not been shortlisted on this occasion.
By applying for this vacancy, you accept Lloyd Recruitment Services Privacy and GDPR Policy which can be found on our website and therefore gives us consent to contact you.
Lloyd Recruitment Services are acting as a recruitment agency in relation to this vacancy and are an equal opportunities employer.
