Regulatory Affairs Manager
Our Client, a leading MedTech Company in Galway City is hiring a Regulatory Affairs Manager. The successful applicant will manage a team of four RA Specialists, The RA Manager will also be responsible for the management and maintenance of existing global regulatory approvals and filings in new territories for Class IIb and Class III devices.
- Manage and maintain existing global regulatory approvals and filings in new territories.
- Manage regulatory submission timelines, identify risks and appropriate mitigations.
- Develop and advise on regulatory strategies for existing and changing products in collaboration with R&D, Manufacturing and Quality Assurance departments, as appropriate.
- Lead regulatory team members ensuring resources and expertise are assigned to meet company goals and objectives. Guide, coach, direct and develop direct reports.
- Manage EU vigilance, US MDR and other approved territory reporting activities ensuring all regulatory reporting timelines are met.
- Co-ordinate and support regulatory reviews and meetings with regulatory authorities ensuring effective internal and external communication to ensure queries are addressed in a timely and effective manner.
- Review and approve product labelling changes, promotional literature and marketing materials prepared by the Company and its distributors
- Provide input to regulatory aspects of design control, change control, and nonconforming processes. • Compile/review regulatory documentation to support global pre- and post-market clinical study submissions.
- Participate as a Clinical Project team member to provide regulatory oversight of clinical operations including provision of support for safety reporting and preparation of clinical study reports.
- Provide a regulatory interface to the company’s clinical and commercial operations. • Maintain knowledge of current regulatory environment in relevant markets to ensure that information is adequately communicated throughout the company relating to changes in the regulatory environment.
- Fulfil assigned aspects of the role of the Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the EU MDR.
- Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, MDR 2017/745, FDA Quality System Regulations 21 CFR Part 820, ISO 14971, and Japanese Ministerial Ordinance #169
- Assist with training of company employees in relevant areas of regulatory affairs
- Provide regulatory oversight of customer complaint handling process.
Manage assigned aspects of the Quality System, as required. Assist in the preparation and conduct of regulatory and quality system audits.
- Minimum 8 years’ experience in regulatory affairs, ideally with Class IIb and Class
III cardiovascular medical devices.
- Bachelor’s or Master’s degree in science, pharmacy, engineering or life-sciences related
- Previous experience in drug/device combination product filings highly preferred.
- Technical competency of ISO13485:2016, MDD 93/42/EEC, MDR 2017/745, and
the FDA QSRs is a prerequisite.
- Understanding of regulatory strategy and determination of documentation
requirements, timelines, budgets and filing options.
- Excellent oral and written communication skills. Negotiation abilities to identify and
resolve issues; highly organised.
- Prioritise own workload and the workload of the project team to achieve project
- Willingness and availability to travel on company business.
- Proficient in all Microsoft Office applications.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.
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