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Job Title: Senior Regulatory Engineer
Location: Lancing, West Sussex
Hours of work: 37.5
Salary: £45,000 - £55,000
The current Quality and Regulatory Manager is planning to retire within the next 12 to 24 months and as such 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.
- 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)
- 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.
- Computer literate.
- Experience with supervision of technical and regulatory professionals is desirable.