Regulatory Affairs Manager

Recruiter
Meadowbank Associates
Location
Newcastle
Salary
Competitive
Posted
02 Aug 2018
Closes
29 Aug 2018
Job Type
Manager
Contract Type
Permanent

This is a new role my client and the successful candidate will quickly become a key member of the Compliance Department.

Key duties and responsibilities for the Regulatory Affairs Manager will include:

  • Registering and maintaining Company registration in accordance with specified country requirements
  • Reporting to the Compliance Director on all matters pertaining to regulatory activities in order to perform and maintain a regulatory management role which is independent of the purchasing, manufacturing and testing functions
  • Authority to control further processing or delivery of nonconforming product until the nonconformity is resolved
  • Assessing the impact of design changes for regulatory compliance and the implications for maintaining product registration
  • Authority to release product on concession if regulatory requirements are met
  • Promoting awareness to staff on meeting customer, quality and regulatory requirements
  • Reporting the implications of regulatory changes to Management Review
  • The responsibilities of the Regulatory Affairs Manager may be delegated to the Quality Manager or a senior Quality Coordinator during absence

Key skills and experience required:

  • Quality and/or regulatory experience required (ideally within the medical/pharmaceutical industry)
  • Management of time-sensitive projects and priorities
  • Implementation of regulatory requirements seamlessly into business practice
  • Ability to make balanced decisions based on objective evidence
  • Ability to contribute knowledge and skills that complement other team members
  • Excellent communication skills
  • Strong customer focus

Candidates will be educated to Degree level (or equivalent) or have a relevant experience/qualification.

Hours of work: Monday - Friday, 9.00am - 5.00pm

Holidays: 20 days + bank holidays

Onsite parking

Professional working environment