About the Role
Are you an experienced Quality professional seeking a new challenge? If so, Taylored Consultancy has the perfect opportunity for you!
Founded in January 2023, Taylored Consultancy has been experiencing rapid growth and is now looking for a Compliance Associate to join our expanding team! We support a wide variety of businesses, from cutting-edge start-ups to S&P 500-listed multinational companies, offering a refreshing, strategic, and commercially focused approach to Compliance consulting.
As a member of our team, you'll have the chance to work across diverse industries such as medical devices, food supplements, and cosmetics, within a dynamic and stimulating environment. This role offers significant opportunities for personal and professional growth. As an early-stage business, you'll play a key role in shaping the company’s success, while gaining access to a range of career advancement opportunities.
Role Description:
Job Title: Compliance Associate - Permanent - Full Time
Work Model: Hybrid (2-3 days in office)
Location: Birmingham, UK
Responsibilities, including, but not limited to:
Internal Audits and Inspections for external customers:
· Assist in planning, conducting, and following up on internal audits to assess compliance with ISO 9001, ISO 13485, MDR 2017/745 and other applicable regulations.
· Support the preparation for external audits and regulatory inspections.
· Track audit findings and ensure corrective actions are addressed and implemented.
ISO 9001 & ISO 13485 Compliance internally and for external customers:
· Assist in the implementation, maintenance, and continuous improvement of the QMS.
· Ensure all processes are aligned with ISO 9001 and ISO 13485 requirements.
· Provide gap analysis reports of QMS against applicable standards.
Training and Documentation:
· Compile and support the development of training materials and sessions relating to QMS requirements which will be delivered to customers
· Develop practical checklists to support customers which can also be downloaded from our website
Administrative tasks
* Attend prospect meetings and onboarding new clients
* Attend client meetings both remote and onsite as and when needed
* Liaise with Notified/Approved Bodies and Competent Authorities where applicable
* Attend exhibitions, conferences, and network events
Essential Requirements
* Minimum of 2-3 years of experience in Quality within the medical device Industry.
* Experience of auditing either internally or at a lead auditor level to ISO 9001 or ISO 13485.
* Must be eligible to work in the UK
* Willingness to learn and grow: We are looking for a motivated candidate who is eager to learn and grow as part of a team. A willingness to continuously develop your skills and contribute to the team’s success is essential
* Excellent communication and interpersonal skills
* Ability to work independently and as part of a team
* Attention to detail and strong analytical skills
* Commercial mind set and energised by a fast paced, dynamic environment
Desired
* MDR 2017/745 experience
* US FDA experience
* Regulatory experience or knowledge of regulatory
Benefits
Competitive Salary and compensation package: We understand the value of your skills and expertise. We offer a competitive salary, pension and other employee benefits!
Professional growth and development: As a Compliance Consultant, you’ll have the opportunity to work on a diverse range of projects within difference regulated industries. As a small company you have the scope to expand your role and grow with the company.
Dynamic work environment: Join a team that works across multiple industries and a wide range of customers, where every day brings new challenges and opportunities to make a difference. You will get to work directly with the clients, watch them grow and help them launch new products!