Regulatory Affairs Manager

About the role:

The primary responsibilities of the position are to ensure regulatory compliance of a defined group of ConvaTec products, drive regulatory processes and activities (such as regulatory strategy, product registration, change control, review of marketing materials) and continue to develop strong working relationships with internal and external stakeholders. The person will be responsible for the management of global and regional regulatory projects, including, but not limited to, the regulatory aspects of product life cycle and changes to existing products.

Your key duties and responsibilities:

• Provide managerial oversight, resource and workload allocation for a team of up to seven Senior/Regulatory Affairs Specialists.

• Advise on strategies and registration requirements for changes to marketed products and roll out of products in new markets.

• Manage and develop a team of regulatory professionals, including identifying the need for training, conduct trainings and/or communicate appropriate materials, as needed, to enhance the team’s knowledge of working in a regulated environment.

• Ensure Regulatory compliance to maintain market approvals.

• Foster thorough knowledge of regulatory principles and compliance with regulatory policies throughout the organization through training and mentorship.

• Regulatory support to enquiries from customers and authorities.

• Oversee, provide guidance, and if necessary, write and submit US FDA submissions, including 510(k)s, De Novo, etc, and EU MDR Technical Documentation, and interface with authorities during the review process.

• Provide guidance to business partners (internal and external) and regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes. Supports currently marketed product portfolio.

• Review, interpret and communicate FDA/EU/international regulations and guidance documents to ensure complete and scientifically sound product submissions.

• Support base business activities, such as Annual Reports, Supplements, Labelling reviews, UDI and Change Management reviews for regulatory submission impact.

• 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.

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

• Perform other duties as assigned.

Skills & Experience:

• 4-10 years relevant experience, preferably in a regulatory affairs role in the life science industry.

• Demonstrated experience with EU Medical Device Regulations (MDR) 2017/745, including preparation and maintenance of Technical Documentation and interaction with Notified Bodies.

• Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA.

• Experience authoring and submitting medical device registrations/ licenses/submissions applicable to regional area.

• Experience reviewing product labelling and advertising/promotional material for medical devices.

• Experience supporting change control and new product development projects.

• 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.

• Logical Thinking Skills and Experience: demonstrated ability to analyse and interpret complex problems / data gathered from a variety of sources and utilize.

• Statistical knowledge, experience is desirable.

• Management or supervisory experience required.

Qualifications/Education:

• Level of education required to have been achieved - Life Science Degree level or equivalent

• RAPS Certification preferred.

Travel Requirements:

• Position may involve travel up to 25% of the time. Some trips may include overnight travel.

Working Conditions:

• This role may be based in Søborg/Osted with a hybrid working structure.

Special Factors:

• 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 and/or project/international customer support required.