Regulatory Affairs Manager (Hybrid) with significant experience in a similar role in compliance with FDA and EU guidelines required by Biotech multinational in Dublin.
To be considered, you must be authorised to work in Ireland.
The successful professional will be responsible for applying tactical direction for global registrations for assigned devices while engaging with the regulatory team for devices and providing appropriate guidance and oversight to device development teams.
Requirements:
- Bachelor’s or Master’s Degree in a Scientific discipline or similar required.
- A minimum of 8 years’ experience required in a similar role.
- At least 3 years of Regulatory standards experience required.
- Current knowledge of FDA and EU guidelines and regulations.
- Working knowledge of other international regional/country regulatory requirements.
- Basic knowledge of the regulatory environment in areas of commercial interest and its impact on regulatory strategy and implementation.
- Understanding of regulatory agency philosophy and guidelines.
- Experience managing preparation of IDEs, 510(k)s, PMAs.
- Good fundamental knowledge of device therapeutic areas
- Proven ability to prioritize and meet project deadlines.
- Excellent problem identification and solving skills, e.g. risk management planning.
- Able to effectively apply knowledge of the industry and competitive environment to regulatory practice.
- Ability to organize resources and manage cross functional dependencies.
- Can work independently with limited supervision and on complex issues/projects.
- Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.
ADVANTAGEOUS:
- Basic knowledge of EDMS system.
- RAC certification.
Responsibilities:
- Act as a Leader for the device regulatory team supporting assigned product portfolio to develop and implement regulatory strategies to secure global device licenses and approvals.
- Manage the content of global regulatory dossiers.
- Key internal leader and driver of regulatory policy and strategy for assigned products.
- Anchor preparation of global, US and Canadian regulatory product strategies for assigned products.
- Guide the regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for product portfolio.
- Ensure alignment of regulatory strategy and business objectives.
- Lead preparation of post-filing communications and deliverables.
- Engage with project teams to ensure required regulatory contributions meet business needs and are provided to the project teams, to agreed time, cost and quality standards.
- Ensure modifications/variations in regulatory plans are communicated to RA Management.
- Ensure regulatory strategy is developed for all key issues for product portfolio.
- Participates in educational and business activities leading to basic knowledge of the therapeutic area.
- Communicates effectively in a means appropriate to the setting.
Our client offers a range of work benefits such as Health Insurance, Bonus, Paid AL, Family healthcare and pension.
Send your CV in confidence to emer@emtechrecruitment.ie
