"Alerted.org

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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

Position Overview:

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 across the entire Regulatory Affairs group. Individuals will be expected to drive regulatory processes and activities (such as regulatory intelligence, global registrations, review of marketing materials, etc.) and continue to develop strong working relationships within RA group as well as internal/external customers. The person will be responsible for the management of global and regional regulatory operations projects and supporting other regulatory projects as required.

Key Responsibilities:

+ Work independently to manage range of Regulatory requests received from internal and external stakeholders in support of global regulatory and commercial activities, including new, renewal and change submissions.

+ Assist with day-to-day operational objectives for the team, as required.

+ Review, interpret and communicate international regulations and guidance documents to ensure complete and scientifically sound product submissions, as required.

+ 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.

+ Generate and approve regulatory technical documents for various global markets in support of global regulatory and commercial activities, utilizing knowledge and experience to ensure maintenance of Regulatory compliance.

+ Lead discussions with cross-functional stakeholders to drive preparation of supportive documentation, including technical and legal documentation, required in support of global regulatory and commercial activities.

+ 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.

+ Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes.

+ Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship, including driving the maintenance of the comprehensive Regulatory Intelligence system.

+ 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

+ Support base business activities, such as Monthly Reports, master data management, portal/listing information, annual establishment reviews.

+ Liaise with external consular services agents to coordinate and arrange notary, apostille and legalization as required.

+ 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

+ Participates as an active member of Industry, Regulatory or Scientific Committees, as appropriate

+ This position serves as a delegate for the line manager stated on this job description

+ Perform other duties as assigned

Authority (if applicable):

To compile and sign truthful and accurate technical documents to support device registrations for all business units.

To raise orders for required certificates of free sale or equivalent utilizing company credit card and accurately managing associated expenses. Expenditure over and above the initial expected outlay must be discussed and agreed by Senior Manager, or higher prior to execution.

Skills & Experience:

+ 2-5 years relevant experience, preferably in a regulatory affairs role in the life science industry

+ Experience dealing directly with Notified Bodies and global regulatory authorities.

+ Experience authoring and submitting regional technical documentation supporting global registrations across multiple territories globally

+ Experience reviewing product labeling and advertising/promotional material for medical devices

+ Continuous improvement mindset with track record of implementing process improvements for regulatory affairs systems.

+ Experience of regulatory requirements for medical devices containing animal derived materials 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

+ Demonstrate excellent communication skills

+ Demonstrate strong organizational skills, including the ability to prioritize workload

+ Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial

Qualifications/Education:

+ Preferred Education: Life Science Degree or equivalent.

+ RAPS Certification preferred.

Dimensions:

Team

Part of a small team.

Reporting to Senior Manager – International Regulatory Affairs, additional direction from Sr. Director, Regulatory Affairs Ostomy Care & Continence Care

Principal Contacts & Purpose of Contact

Primary contact will be with the GEM team and other Regulatory colleagues located in local market offices as the main submitters of Reg Ops requests. Will also interact with Regulatory colleagues across all BUs and will have interaction with other departments including but not limited to QC and legal in order to support regulatory submissions.

Travel Requirements

Position may involve travel up to 25% of the time, overseas travel is expected. Most trips will include overnight stay(s).

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.

Languages

+ Speaking: Yes English*

+ Writing/Reading: Yes English*

*additional languages as required or nice to have

Working Conditions

This position is remote based, with occasional travel to the office. The office location for this role is Lexington, MA (USA)

Special Factors

Flexibility in working hours required due to time zones of other project team members.

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

\#LI-KM1

\#LI-Remote

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’re unsure, please contact us at [email protected] .

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!