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Associate Director, Regulatory Affairs
2 months 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 reviewing submissions as part of Notified Body staff including experience with the application process through to CE Mark/UKCA Mark is highly preferred. Experience with PRRC or Legal Representative / Authorized Representative activities is advantageous. The ability to manage and own projects with little oversight is expected.
Responsibilities and Duties
- Develop and execute regulatory services for client companies, including however not limited to:
- Regulatory Submission Documentation (e.g., Technical Documentation, , CERs required; documentation for US, Canada and other regions is advantageous)
- Regulatory Strategy, Analysis & Development
- Clinical evidence review and sufficiency assessment
- Design and Review Pre-Clinical Testing
- Post-market surveillance and incident reporting
- 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.
- Work collaboratively with other MCRA departments.
- Stay current on relevant medical device regulatory requirements.
- Attend and present at conferences, webinars and meetings as needed.
- Complete other duties and projects as assigned.
Required Knowledge, Skills, and Experience
- 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., FDA, Notified Body, ISO 13485).
- 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.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Strong written, including medical/technical writing, and verbal communication and presentation skills.
- Possess an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.
- Research, analytical, critical-thinking, and problem-solving skills.
- Able to lead projects with support from MCRA staff and junior team members; takes initiative and ownership of results; demonstrates self-accountability.
- Strong organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines.
- Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus).
- Must be punctual, polished and professional.
- Effective interpersonal skills; shows confidence with subject matter and “calm under pressure” approach and style.
- Strong client focus and relationship management skills.
- Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
Supervisory Responsibilities
- Ensure work meets client and company standards.
- Oversee the day-to-day workflow.
Work Environment
- Collaborative with a strong team spirit.
- Interaction with peers, subordinates, and managers.
- Entitled to a work environment that is free from harassment.
Travel Required
Occasional travel (< 10%) may be required.
Affirmative Action/EEO statement
We are an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
