Manager, Regulatory Affairs

Overview

The primary function of this role is to supervise the Regulatory Affairs area to ensure that it runs in a smooth and efficient manner. Function will involve a thorough understanding of both the regulatory requirements required for the Medical Device Industry.

Reporting to: Director, Regulatory Affairs

Find out more about Cook Medical here

Responsibilities

• Responsible for supervising the day to day workload and operational issues of the regulatory affairs team. This includes, but is not limited to, setting team and individual objectives, carrying out performance appraisals, generating training plans and dealing with performance related issues.
• Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required and other jurisdictions as required.
• Maintains an excellent understanding of the global medical device regulations.
• Actively pursues ways in which to improve the function of the Regulatory Affairs Department.
• Monitors the progress of RA team members on assigned tasks, and removes roadblocks.
• Works with senior management to allocate sufficient resources to complete projects in a timely manner.
• Provides direction and logistical support to the RA team members to complete assigned tasks.
• Fosters accountability within the team to meet established timelines.
• Mentors and trains new RA team members.
• Highlights any updates to regulatory requirements to Senior Management.
• Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
• Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
• Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
• Advise other Cook functional units (engineering, marketing, operations, quality etc.) of the requirements in each target market and updates same on approval status in target markets.
• Ensures the clinical requirements of the product are adequately addressed.
• Ensure the outputs from the individual functional units (engineering, biocompatibility, marketing etc.) meet the applicable regulatory requirements.
• Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
• Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
• Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Maintains a system for registration information (license numbers, expiration dates etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
• Provides support to currently marketed products as necessary including input on change requests, etc.
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
• Provides regulatory support to Cook functional units such as the customer support and delivery centres, tenders, customer quality and distribution.
• Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
• Performs additional duties as assigned.
• Delegate for Person Responsible for Regulatory Compliance (PRRC) as per Regulation (EU) 2017/745.Ensure that the technical documentation and the declarations of conformity are drawn up and kept up-to-date.
• Ensure that the post-market surveillance obligations are compiled with as per current EU regulations (Article 10 (10)) of the MDR:2017.
• Ensure that in case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued .

Qualifications

• Third level Qualification preferably in Science/Quality, 10 years' experience in a regulated industry in a similar role is desirable.
• Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
• Knowledge of requirements in other jurisdictions where required.
• Knowledge of medical device quality standards/practises or similar regulated industry.
• Good communication and inter-personal skills.
• Proven problem-solving skills.
• Good computer skills including knowledge of Microsoft Office.
• Proven organisational skills.
• High self-motivation.
• Willingness and availability to travel on company business.
• To cover the role of delegate for Person Responsible for Regulatory Compliance (PRRC) as per Regulation (EU) 2017/745 the following are required:
• a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in Regulatory Affairs or in Quality Management Systems relating to medical devices or
• b) four years of professional experience in Regulatory Affairs or in Quality Management Systems relating to medical devices .
• Note: For the purpose of fulfilling the requirement for PRRC laid down in point "a" of Article 15 (1), any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognised by an EU Member State as equivalent to the EU corresponding qualification.