Associate Director, Regulatory Affairs - Europe

MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creatorsregulatory, clinical research, reimbursement, healthcare compliance, and quality assuranceto provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
OverviewThe Manager, Regulatory Affairs is a critical team member supporting regulatory strategy and submissions for the firms 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 with support of senior MCRA staff, as needed. 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 or 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 Submissions (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 Review Pre-Clinical Testing
• 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 with support of senior MCRA staff, as needed.
• Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance.
• Stay current on relevant European regulatory requirements.
• Attending conferences 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 five 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.
• An understanding of clinical research and data analysis is required.
• Possesses 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.
• Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.
• Possesses 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.
• Strong 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.
• Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines.
• PC/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.

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