Buscojobs | Regulatory Affairs Specialist
Vor 3 Tagen
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 Convatec.
Job Summary
The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems, and infrastructure whilst supporting regulatory strategy and registration across global markets and across the whole Regulatory Affairs group.
Individuals will be expected to help drive regulatory processes and activities (such as regulatory intelligence, global registrations, review of marketing materials, etc.)
and continue to develop strong working relationships with the rest of the RA group as well as internal and external customers.
The person will be responsible for the management of global and regional regulatory projects, including, but not limited to, the regulatory aspects of new product development, product life cycle, and changes to existing products.
Key Responsibilities:
Take ownership of, and manage, Regulatory requests received from internal and external stakeholders in support of global regulatory and commercial activities, including new, renewal, and change submissions.
Generate and approve regulatory technical documents for various global markets in support of global regulatory and commercial activities.
Liaise with internal stakeholders to coordinate the preparation of documentation, including technical and legal documentation, required in support of global regulatory and commercial activities.
Generate and execute regulatory strategies for phased launches of new, renewal, and change submissions and other major projects whilst liaising with and managing internal and external stakeholders to a defined timescale.
Work with Regulatory colleagues in local markets to monitor pending and in-process submissions and communicate to management any identified delays that may impact business expectations.
Ensure Regulatory compliance to maintain market approvals.
Liaise with external consular services agents to coordinate and arrange notary, apostille, and legalization as required.
Support the business with the implementation and execution of a comprehensive regulatory intelligence system and supporting services.
Encourage the improvement and alignment of processes across the Regulatory Affairs group.
Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship.
Support base business activities, such as Monthly Reports, master data management, portal/listing information, and annual establishment reviews.
Identify and support or lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation of new internal policies and procedures, and maintenance of existing procedures.
Supports regulatory compliance to QSR, ISO, MDSAP, CE, and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systems.
Regulatory review and approval of documents supporting the QMS and product registrations.
Maintaining all submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
General administration duties, including but not limited to the maintenance of the Regulatory Operations mailbox and raising purchase requisitions on behalf of the global regulatory team.
Identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs.
Skills & Experience:
Regulatory / Quality experience in medical devices.
Experience dealing directly with Notified Bodies and global regulatory authorities.
Preparation and submission of regional technical documentation supporting global registrations across multiple territories.
Continuous improvement mindset with a track record of implementing process improvements for regulatory affairs systems.
Experience with regulatory requirements for medical devices containing animal-derived materials is preferred.
Experience of regulatory requirements for medical devices with an Ancillary medicinal substance preferred.
Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971.
Qualifications / Education:
Preferred Education: Life Science Degree or equivalent.
RAPS Certification preferred.
Travel Requirements:
There may be some business-related travel associated with this role dependent on project and/or local market and UK travel associated with this role because some team members are home-based and face-to-face contact with line manager and peers may be required.
Attendance of relevant training and development events would be required.
Some destinations may involve overnight stay(s).
Working Conditions:
This position is hybrid with a minimum expectation to travel to the office in Deeside for 1-2 days every other week.
There may be rare instances whereby an employee may be required to work outside of non-core hours/days.
This may be due to an unexpected event, crisis, or project timeline pressure as may occur within the regulatory affairs industry.
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.
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