Regulatory Compliance Associate
6 days ago
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.
- 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
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.
- Teamworking
- Passion for Results
- Personal Accountability
- Open and Transparent
- Developing Self and Others
- Innovation
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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