Regulatory Affairs Officer

5 months ago

London, United Kingdom Farla Medical Full time

**Position Overview**:
**Responsibilities**:

- Develop and implement a robust compliance program to ensure adherence to the GPSR and other relevant regulations governing product safety.
- Conduct comprehensive audits and assessments to verify compliance with GPSR requirements throughout the product lifecycle.
- Collaborate closely with cross-functional teams, including product development, manufacturing, and regulatory affairs, to integrate GPSR compliance into product design and manufacturing processes.
- Stay abreast of updates and changes to GPSR regulations and guidelines, and ensure timely implementation of necessary revisions to processes and procedures.
- Review product specifications, labelling, and packaging to ensure compliance with GPSR requirements and other applicable regulations.
- Investigate incidents, complaints, and non-conformities related to product safety, and implement corrective and preventive actions as necessary.
- Provide training and support to internal teams on GPSR compliance requirements, processes, and best practices.
- Liaise with regulatory authorities and certification bodies to facilitate product certifications and approvals.
- Maintain accurate documentation of compliance activities, including audit reports, regulatory submissions, and corrective action plans.
- Drive continuous improvement initiatives to enhance GPSR compliance processes and systems.

**Qualifications**:

- Bachelor's degree in a relevant field such as Quality Assurance, Regulatory Affairs, Engineering, or a related discipline.
- 1+ years of experience in quality assurance, regulatory compliance, or a related field, with a focus on GPSR compliance.
- In-depth knowledge of the GPSR and other relevant regulations governing product safety.
- Experience conducting compliance audits and assessments, preferably in a manufacturing or product development environment.
- Strong analytical and problem-solving skills, with keen attention to detail.
- Excellent communication skills, both verbal and written, with the ability to effectively communicate complex regulatory requirements.
- Ability to work collaboratively in a cross-functional team environment and effectively influence stakeholders at all levels of the organization.
- Certification in quality management or regulatory affairs is advantageous.
- Familiarity with risk management principles and methodologies is desirable.

**Salary**: £28,000.00-£30,000.00 per year

**Benefits**:

- Cycle to work scheme
- Employee discount
- Free parking
- Health & wellbeing programme
- On-site parking
- Store discount

Schedule:

- 8 hour shift
- Monday to Friday
- No weekends

Supplemental pay types:

- Yearly bonus

**Experience**:

- Regulatory Affairs: 1 year (preferred)
- Quality management: 1 year (preferred)

Work Location: In person

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