Managing Consultant at LifeScience Recruitment
Job title:
Sr Regulatory Affairs Manager
Location:
Mervue, Galway
Benefits:
Top salary, bonus, pension, healthcare and car allowance
Overview:
As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products.
This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements.
Role
Regulatory Strategy & Product Development:
Support the development and implementation of global regulatory strategies throughout the product lifecycle, from R&D through commercialization and post-market activities.
Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into development plans and timelines.
Provide regulatory guidance on product submissions (e.g., 510(k), etc.
)
Market Access & Submissions:
Oversee the preparation, review and submission of regulatory filings in the US and EU.
Liaise with regulatory bodies (e.g., FDA, Notified Body) to facilitate product approvals and resolve regulatory issues as needed.
Team Leadership & Development:
Manage resources across assigned product programs, aligning activities with departmental priorities.
Support team structure, talent development and professional growth of regulatory staff.
Mentor and coach team members to build regulatory expertise.
Risk Management & Compliance:
Identify potential regulatory risks and contribute to the development of mitigation strategies.
Stay informed on evolving regulatory trends and changes, providing timely guidance to teams.
Business Initiatives:
Participate in business initiatives by providing regulatory input and supporting due diligence for new ventures and partnerships.
Experience required
Level 8 degree in a scientific or engineering field with a minimum of 7 years' experience in regulatory affairs for medical devices, of which at least 5 years included leadership experience through direct management and/or mentorship/advisory capacity.
Alternatively, an advanced degree with a minimum of 5 years' experience in regulatory affairs for medical devices and at least 5 years of leadership experience through direct management and/or mentorship/advisory capacity.
Leadership: Experience in a regulatory affairs leadership role, with a record of managing teams and supporting departmental goals.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Management
Industries:
Medical Equipment Manufacturing and Biotechnology Research
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