Regulatory Compliance Associate

6 days ago


Hemel Hempstead, Hertfordshire, United Kingdom Merz Aesthetics UK and Ireland Full time
About the Role

Merz Aesthetics UK and Ireland is seeking a highly skilled Quality Assurance Associate to support the QA Manager in ensuring the quality management system operates efficiently and effectively.

Key Responsibilities
  • Quality Documentation: Develop, implement, and maintain quality documentation, including procedures, work instructions, and records.
  • Quality Management Systems: Support the implementation and maintenance of quality management systems, including ISO 13485 and other relevant standards.
  • Risk Management: Identify, assess, and mitigate risks associated with quality management and compliance processes.
  • GDP Training and Education: Develop and deliver training programs to ensure employees understand Good Distribution Practice (GDP) and quality management principles.
Main Working Relationships
  • Quality Assurance Manager, line manager
  • Financial colleagues and Customer Services to ensure activities are aligned with process and compliant
  • Medical affairs colleagues (Regulatory Affairs, Scientific Advisors, Medical Scientific Liaison, Medical Information Scientists) as well as the License Holder and Finance Director
  • Commercial colleagues in marketing and sales to ensure activities are fair, balanced and compliant
Qualifications, Experience & Knowledge Requirements

Mandatory:

  • A minimum of a BS preferably in Chemistry or Life Sciences.
  • Minimum of 2 years of experience in medical devices or pharma industry in a quality assurance role, or other relevant experience regulated industry.
  • Strong written and verbal communication skills, analytical and data analysis, problem solving, and conflict resolutions skills.
  • Exceptional organisation skills, demonstrable ability to manage multiple workstreams concurrently.
  • Flexible, highly motivated, must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
  • Ability to work within a cross functional team, managing multiple stakeholders.
  • Effective interpersonal skills with the ability to communicate at all levels withing the organisation, concisely and clearly communicating complex and unfamiliar topics and ensuring understanding.
Competency Requirements
  • Teamworking
  • Passion for Results
  • Personal Accountability
  • Open and Transparent
  • Developing Self and Others
  • Innovation
About Us

Merz Aesthetics is a leading company in the field of aesthetic medicine, committed to advancing medicine in aesthetics and striving to fulfil its vision: To help people look better, feel better, and live better.

We offer an aesthetic portfolio with a range of treatment options (device and injectables) that allows Healthcare Professionals to use Merz Aesthetics technologies to treat a broad range of patients' concerns.



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