Those who join our client as employees feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Reporting to the Device Regulatory Affairs Lead, the Director of Regulatory Affairs will oversee and establish the regulatory activities and strategies for the Company’s device product portfolio. The Director, Regulatory Affairs (RA) is responsible for leading the development and implementation of RA strategies for the device franchise, and for establishing optimal regulatory positions for new products and existing commercial products.
- Directs and develops regulatory group and/or team supporting the device portfolio at one or more company sites
- Establish overall regulatory strategy for device product portfolio, working closely with the head of R&D, Tech Ops and Commercial to ensure appropriate lifecycle planning.
- Provide regulatory guidance to cross-functional groups regarding strategic aspects of manufacturing, quality, preclinical and clinical development and testing for device portfolio; identify options and influence decision.
- Directs efforts for planning and execution of required regulatory filings; oversee development of submission content and documents – provide guidance when appropriate
- Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure approvals are obtained.
- Plan, prepare and execute for meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies and build rapport with regulators to best position for positive outcomes.
- Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches
- Provide critical review of documentation supporting regulatory applications; analyse and resolve submission issues and identify new content as needed
- Ensure RA activities are aligned to project timelines & business objectives and are compliant with ICH, FDA, HC, and EU regulations
- Maintain knowledge of regulatory environment, regulations and guidance
- Interact with company partners and consultants for various regulatory matters as needed
- Contribute regulatory perspective as needed on government proposals and external due diligence activities
- Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs; maintain currency and compliance with regulatory systems and understands external trends
- Collaborate with business and technical groups on content of labelling
- Monitor key competitor positioning and determine impact to strategy
- Provide input into Regulatory Vision and develop operational plans
- May be responsible for team budget
- BS degree in related biological and life sciences field (MS or PhD preferred)
- 12+ years of industry experience in Regulatory Affairs for pharmaceutical drug and/ or devices withsome experience in OTC products
- Management of a group including evaluation of performance.
CV to Gerry Kennedy The RFT Group firstname.lastname@example.org 01 2302400