Associate Regulatory Affairs Director I
1 week ago
Overview The Associate Director, Regulatory Affairs - Europe is a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include writing, reviewing, and managing regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA.
This open position is a remote-based employee located in Europe with expertise in EU MDR and UK MDR. Experience with PRRC or Legal Representative / Authorized Representative activities is advantageous. The ability to manage and own projects with little oversight is expected.
Develop and execute regulatory services for client companies, including however not limited to:
Regulatory Submission Documentation (e.g., Regulatory Strategy, Analysis & Development
Perform business development functions to secure new clients and projects.
Review and oversee technical writing and regulatory submission development by junior team members.
Communicate with regulatory bodies and clients.
Stay current on relevant medical device regulatory requirements.
Complete other duties and projects as assigned.
Bachelors degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
Minimum 8 years of experience in Regulatory Affairs related to medical devices, drugs and/or biologics, developing regulatory deliverables and submissions. Work experience must include writing and/or reviewing of regulatory submissions.
Direct notified body regulatory review experience
An understanding of clinical research and data analysis is required.
US and/or International regulatory experience/fluency with regulations (e.g., Domain specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise may advantageous.
Understanding of your team's regulatory landscape, including the breadth of services, how they interact, and how data flows between deliverables.
Strong written, including medical/technical writing, and verbal communication and presentation skills.
Able to lead projects with support from MCRA staff and junior team members; Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus).
Strong client focus and relationship management skills.
Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
Travel Required
Occasional travel (
We are an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need.
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Associate Director, Regulatory Affairs
1 week ago
United Kingdom MCRA Full timeOverview The Associate Director, Regulatory Affairs - Europe is a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include writing, reviewing, and managing regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and...
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Associate Director, Regulatory Affairs
1 week ago
United Kingdom MCRA Full timeOverview The Associate Director, Regulatory Affairs - Europe is a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include writing, reviewing, and managing regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and...
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United Kingdom MCRA, an IQVIA business Full timeOverviewThe Associate Director, Regulatory Affairs - Europe is a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include writing, reviewing, and managing regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and...
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United Kingdom MCRA, an IQVIA business Full timeOverview The Associate Director, Regulatory Affairs - Europe is a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include writing, reviewing, and managing regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and...
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