SRG are working with an exciting biotechnology organisation with a global presence to help them find a Team Leader within Regulatory Affairs (RA).
This is a great opportunity for someone with a wealth of experience in the field of Regulatory Affairs within IVD/IVDRs to take on a new challenge.
The company offer an excellent benefits package and opportunity for development.
The Role:
Manage the business priorities and technical contributions of a team of regulatory administrative staff, regulatory officers and senior regulatory officers with accountability for the performance and results of the team.
Manage team resources and set priorities to ensure alignment of regulatory support with product development activities and regulatory reporting obligations.
Mentor, train and develop junior regulatory affairs team members; develop and support individual training and development plans for line-managed team members to achieve required team performance.
Collaborate with Regulatory Affairs Technical Leads to identify technical training needs for junior regulatory staff and ensure the continuous development of staff capabilities and preparation of high-quality regulatory assessments and submissions.
Assist the Regulatory Affairs department leader in recruitment of junior staff
Actively participate in multifunctional IVDR project team and lead the regulatory contribution to manage regulatory resourcing and ensure high quality submissions and timely certification to meet regulatory and business needs.
Actively participate in multifunctional project teams to provide guidance on regulatory requirements, provide supporting regulatory documentation, advise team members on data and information required for successful license applications, including reviewing of analytical study protocols/reports to ensure regulatory requirements are met.
Prepare and compile regulatory documentation, coordinate and execute regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) - Part 1 and other country requirements as appropriate.
Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information.
Ensure maintenance of product regulatory documents and technical files to ensure ongoing compliance.
Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the relevant Regulatory Authorities.
Complete routine regulatory reporting required as a condition of approval (FDA Annual Report).
Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), 13485 standards, IVD 2017/746 Regulation, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.
Contribute to the design and implementation of regulatory processes, identify areas for potential improvement and propose solutions.
Provide regulatory support during external audits by regulatory authorities and address any findings or corrective actions required as a result of inspections or audits.
Requirements:
A relevant science degree and/or relevant work experience in a regulatory affairs environment.
Extensive regulatory experience in medical device / IVD / biotech industry.
Experienced in meeting with, making presentations to, and negotiating with regulators.
Knowledge and practical experience of CE (IVDR) and associated submissions.
Ability to prepare coherent regulatory reports and filings.
Experience of team management, expertise in management of business contributions and development of junior staff.
Great attention to detail with a thorough and methodical approach to work. Ability to analyse information in a logical manner.
Effective relationship building, negotiation and influencing skills both internally with other functional teams and externally with regulatory bodies, customers and distributors.
Strong time management and prioritisation skills, able to work in a fast-paced work environment and respond flexibly to meet changing deadlines and priorities.Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy
