We are continuing our partnership with one of our thriving international scientific healthcare partners based in Stevenage who have grown at an accelerated pace over the last 30 years. This is a family-owned business who have an established relationship with the NHS since COVID-19. They have released several groundbreaking technologies and are now looking for an experience Regulatory Manager to join a highly successful technical department.
 
The company provides infection prevention and control solutions with a core focus on environmental hygiene and hazardous waste management products. Products include disinfectants, cleaners, decontamination systems, waste bags and protective clothing.
 
The input of this role will shape the future direction of the company and its products. They are responsible for declaring and evidencing regulatory compliance to external parties and horizon scanning for impending changes. The role would be part of the technical department working 3 days onsite and 2 remote.
 
Responsibilities
Company regulatory compliance:

• Maintain company certifications (ISO9001, ISO13485 & ISO14001), involving internal audits, liaising with third party external auditors and setting up new certifications if required.
• Rectifying non-conformances and implementing/monitoring continual improvement processes.

 
Product regulatory compliance:

• Authorising, delegating and providing direct input for activities related to sourcing, developing, changing or removing products and qualifying new suppliers. This can relate to product composition, packaging, labelling and claims in marketing collateral.
• Assisting with domestic and European product registrations.
• Contributing to the product non-conformance system.
• Setting up and running safety data sheet software to support current products and new product development.

 
Other responsibilities:

• Authoring external documents and communications.
• Establishing and maintaining relationships with external consultants and regulators.
• Creating internal standard operating procedures for departments to follow.
• Internal training.
• Maintaining a detailed understanding of the company’s products to aid compliance work.
• Developing and maintaining understanding on regulations relating to all products and company operations, including but not limited to REACH, CLP, BPR, PPE, Medical Devices, CE/UKCA markings, ADR, UN certifications, kite marking, poison centre notifications, UFI numbers and different EN and ISO standards.
• Collection, centralisation, and management of regulatory documentation.
• Maintaining a high level of external visibility on regulations by establishing a network of contacts, regularly attending external events and setting up professional memberships.
• Maintain visibility of costs associated with consultancy, third party testing and company accreditations/memberships to assist the department head perform cost benefit analysis.

 
The head of the technical department may also periodically delegate addition tasks to the regulatory compliance manager which are not captured within this job specification, which they are expected to carry out.
 
Requirements
Essential:

• Degree level qualification in a chemical discipline.
• At least 5 years working in a regulatory compliance role.
• At least 3 years of regulatory experience with chemical products, including REACH and CLP regulations as a bare minimum.

Desirable:

• Regulatory experience of biocides (biocidal product regulations) and/or PPE regulations and/or medical device regulations and/or ADR

 
Skills:

• Excellent written and oral communication skills.
• Ability to quickly learn and implement complex subject matter, often scientific in nature.
• Demonstrate a high level of personal organisation, independence and diligence, effectively managing time and prioritising work.
• A team player with good interpersonal skills and ability to effectively communicate with other colleagues possessing different skill sets.
• Excellent IT skills, including high proficiency with MS Office programs including Word, Outlook, Excel and PowerPoint.
• Ability to effectively record, summarise, report and present data in understandable formats for non-technical colleagues.