Medical Device Regulatory Affairs
3 weeks ago
Regulatory Affairs Officer
Our client is looking to recruit a Regulatory Affairs Officer to work within the regulatory department at their Technical Centre in the Northwest. This position would suit a candidate with some experience in regulatory affairs and offers excellent career progression to a management position in time.
The Regulatory Affairs Officer will be responsible for managing all aspects of regulatory compliance for the company's products as directed by the MD.
Roles and Responsibilities of the Regulatory Affairs Officer:
* Prepare and file regulatory submissions in compliance with government guidelines
* Answering customer enquiries regarding regulatory compliance
* Maintaining databases
* Substance REACH & hazard risk assessment, Materials Safety Datasheet authoring, hazardous labeling packaging & transport. Stay updated on regulatory changes and assess their impact
* Provide regulatory and product safety support by completing customers questionnaires and statements eg. REACH , ISO (Apply online only), food contact plastics & inks
* Communicating with chemical authorities, distributors, regulatory authorities, trade associations and contract manufacturers in the region, to achieve and maintain registrations.
* Develop relationships with regulatory and industry bodies to represent the interests of the organization, gain relevant information and help shape change.
* Liaising with colleagues and external labs to ensure correct analysis and testing is performed
* Complaint processing
Profile of the Regulatory Affairs Officer :
* Experience with Regulatory Affairs
* In return for this Regulatoy Affairs position our client is offering an attractive salary and benefits package, which include 25 days holiday (plus 8 bank holidays).
Whitehall is the Recruitment Specialist for the Chemicals, Resins, Pigments, Coatings, Polymers, Pharmaceutical and Life Science Industries #J-18808-Ljbffr
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