Senior Quality and Regulatory Associate

4 weeks ago

Derby, United Kingdom Getinge Full time

Company description:

Getinge is a leading Medtech company and global provider of products and systems that contribute to saving lives through quality enhancement and cost efficiency within healthcare and life sciences. We employ more than 10,000 people globally and we focus every talent and resource towards helping our customers save as many lives as possible.

Job description:

Senior Quality & Regulatory Associate - Derby, Hybrid

Getinge's Global Centre of Excellence for Chemistry are looking for a Senior Quality & Regulatory Associate to support the Quality and Regulatory Department in the establishment, maintenance, and implementation of the local quality management system in order to comply with applicable regulatory requirements and established standards including ISO 13485, MDR/MDD, 21 CFR 820, REACH.

Day to day responsibilities will include:

Quality Assurance:

Identify areas for improvement. Design, build and implement new quality processes into the organisation. Drive continuous improvement in all aspects of the existing quality operation. Set high standards and lead others to maintain a quality culture across the business.

Champion the quality management system to the wider business to engage compliance within departmental functions. Providing support and guidance as a subject matter expert in the QMS as well as completing functional tasks, as required, within the system including the following:

  • Document control across all tiers of the document hierarchy from the Quality Manual to records.
  • Non-conformance and complaint processing including risk assessment, root cause analysis, CAPA implementation, and data trending.
  • Conduct internal and external audits where required.
  • Implementation of effective supplier evaluation and controls in coordination with the procurement team.
  • Maintain traceable records relating to equipment qualification.
  • Oversee the implementation of an effective local training procedure.
  • Review of batch related documentation including Goods-In, Quality control and DHR.
  • Ensure adherence to management system planning and that changes are effectively implemented across the local organisation.
  • Ensure validation activities for process, equipment, and software are in compliance with local procedures.
  • Participate in compliance audits and support certification maintenance.

Compliance:

Lead, participate in, and ensure adherence to local procedures in:

  • Risk Management according to ISO 14971
  • Post Market Surveillance, Post Market Clinical Follow-up and Vigilance
  • Ensure implementation of labelling compliance activities, updates, and version controls

Regulatory:

  • Review and creation of Technical Documentation as required.
  • Maintenance of medical device registrations with MHRA and EUDAMED
  • Implementation and maintenance of distributor quality agreements
  • Management of global regulatory submission records, communicating with global partners to ensure timely submissions/registrations. Working with internal sales to implement appropriate product sale controls based on regulatory status.

Who you are:

At Getinge, we are looking for passionate individuals, who are agile, resilient, take responsibility for their development and focus on achieving excellence. They never compromise on quality and always act responsibly remembering that our customers always come first. They enjoy collaboration and working in diverse and international teams and embrace the future. If you love change, we can make sure that you stay that way

Knowledge/Skills/Experience:

  • Relevant scientific degree or equivalent in a related discipline
  • Minimum 5 years' experience in a regulated industry within quality and/or regulatory function having effectively used QMS processes such as change control, failure investigation, CAPA.
  • Knowledge of medical device quality related frameworks such as ISO 13485, Medical Device Regulation, 21 CFR part 820 is desirable although consideration would be given to candidates with similar experience in chemical, pharmaceutical, food, cosmetic, automotive industries with translatable skills.
  • IT skills
  • Personal qualities:
  • Ability to work in a fast-paced environment with strict deadlines.
  • Great written and verbal communication skills as you will need to engage positively with different stakeholders across the business.
  • Methodical thinker that can analyse and evaluate root causes of issues.
  • Takes pride in generating detailed, high-quality documentation that is engaging and audit ready.
  • Strategic thinker who actively gains perspective through experiences and developing new skills.
  • Accountability - provide clear and accurate data regarding product and process measurables.
  • Demonstrate good judgement and decision making that is required for effective problem solving.
  • Positive contribution to team objectives, discussions, decisions, and actions.
  • Enthusiasm to drive continuous improvement within quality.

Our Benefits:

We offer:

We offer a competitive compensation & benefits package, including private health insurance, hybrid working, pension contributions, attractive family-friendly policies, wellness and training programs, to ensure we support your wellbeing and success.

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