Senior Quality and Regulatory Associate

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At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.

Are you looking for an inspiring career? You just found it.

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 a competitive compensation and benefits package, including a hybrid working environment, private health insurance, 6.5% pension contributions, attractive parental leave policy as well as wellness and training programs, to ensure we support your well-being and goals.

About us

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise 'Passion for Life' close to heart.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted medtech company.