Regulatory Affairs Specialist

Full Job Description

embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and  Twitter .  

We are hiring for a Regulatory Affairs specialist that will be responsible for supporting regulatory product approval and ongoing activities in the EMEA region in addition to assisting in the development of EMEA Regulatory Strategies.

Responsibilities

• Acts as the Regional RA representative for assigned countries within EMEA region.
• Prepare the registration and/or renewal dossiers of the EMEA products according to the applicable regulatory requirements.
• Ensures the timely and accurate submission(s) of regulatory documentation, along with suitable and precise responses to deficiencies. Coordinates with cross-functional partners on responses, as necessary.
• Acts as the EU MDR Authorized Representative and creates and manages any required responsibilities and/or duties to ensure ongoing EU MDR compliance.
• Assesses changes for regulatory impact and documents via impact assessments.
• Manages local regulatory responsibilities required for assigned countries within EMEA region (i.e., local UDI, local databases, local labeling)
• Collects and manages regulatory data to support EUDAMED requirements. Manages the EUDAMED database on behalf of embecta.
• Interprets application of standards, regulations, and directives to ensure regulatory compliance. Authors impact assessments to external standards as required.
• Collaborates with the Regulatory Affairs strategists and other cross-functional associates to support EMEA submission strategy and ongoing compliance.
• Optimizes in-house tracking tools to track timely approvals, change notifications, renewals, etc.
• Reviews regulatory content within promotional material, labeling, product and process changes, and product documentation and approves on behalf of Regional RA.
• Represents embecta in interactions/negotiations with EMEA Health Authorities including audit support.
• Supporting Regulatory Compliance activities (i.e., recall assessments, reportability assessments, vigilance activities).
• Monitors regulatory developments affecting programs and communicates emerging opportunities and concerns to stakeholders (i.e., manager, Leadership Team, Project Team).
• Ensures compliance with and contributes to the optimization of regulatory departmental policies, procedures, and records in accordance with applicable regulations and standards.
• Completes complex tasks under minimal supervision or guidance.

Experience & Education

• Minimum two years of directly related professional regulatory affairs experience in increasingly responsible positions in the medical device field.
• Fluent English (written and spoken) is required. Additional proficiency in French preferred.
• Working knowledge of applicable external standards related to embecta products and ability to provide insight to cross-functional teams as well as author impact assessments to regulatory related external standards upon revision.
• Demonstrated project management, negotiation, and excellent communication (written and oral) skills.
• Demonstrated global perspective, customer focus, cross-functional collaboration, and teamwork skills.
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism.