Job Description

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

About the role:

Our successful Medical Affairs Specialist Ostomy Care will co-ordinate clinical development and medical affairs activities on a project basis. This may include medical and clinical representation on New Product Development (NPD) Core Teams, Medical/Clinical input and expertise will also be provided for product change control activities, risk management activities (e.g., Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE) preparation, participating in project teams, reviewing Advertising and Promotional Materials from a Medical perspective and providing ad hoc medical advice to support other functions. Additional activities may include supporting medical information request, medical training, support to the local commercial business unit teams, support for organizing advisory boards, aligned with the Medical Affairs and Clinical Development Director Ostomy Care.

Duties and Responsibilities:

• Represent medical / clinical on core/project teams for new product development and change control including risk assessments and IFU development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, and product risk reviews
• Review and approve documents from a medical perspective which include, but are not limited to: Clinical Research Protocols, Clinical Study Reports, and Clinical Evaluation Reports
• Provide medical input into Health Hazard analyses
• Provide medical review support for Medical/Regulatory/Legal (MRL) approval for advertising and promotional material. Working closely with core/project team members to ensure claims and intended use are accurately represented
• Support the complaint handling group, participating in Medical Device Complaint/Malfunction review, ensuring appropriate assessment and guidance in terms of reportability as required
• Consulted for input on the following activities including but not limited to country and site selection, investigator meetings for clinical studies
• Communicates and works closely with other departments such as R&D, Regulatory Affairs, Quality Management and Marketing to ensure timely completion of medical affairs documents for Regulatory filings and medical responses to health authorities.
• Represents ConvaTec and provides medical expertise to relevant teams and External Collaborations: medical information, medical training
• Represent the organization in scientific and professional meetings where appropriate

Skills & Experience:

• Minimum of a bachelor\xe2\x80\x99s degree in Nursing/Allied Health or equivalent Life Sciences with at least 3 years post qualification experience in stoma/ colorectal care.
• Works both as a team member and independently, engages and supports other members of the team and willingly accepts support when required. Is able to make decisions, in consultation, if required, and accept accountability.
• Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.
• Can establish strong working relationships with clinical Investigators and key opinion leaders.
• Shows consistency among principles, values and behaviours.
• Seeks and welcomes feedback, responds to coaching, takes action to change.
• Effective use of oral and written communication skills to influence, inform or guide others.
• Understanding of the medical device industry and of the pre-clinical, clinical, marketing and regulatory components.
• A proven ability to deliver results according to timelines. Anticipates problems and creates solutions to minimize potential delay.
• Solid understanding of project planning and project management methods and the ability to apply them.
• Great communication and interpersonal skills

Working Conditions

This role will predominantly be working from home with occasional travel where needed for team meetings/events.

Our transformation will change your career. For good. You\'ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you\'ll be supported to bring them to life. There\'ll be challenges. But stretch yourself and embrace the opportunities, and you could make your biggest impact yet.

This is stepping outside of your comfort zone.

This is work that\'ll move you.

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Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you\xe2\x80\x99re unsure, please contact us at .

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!

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