Job: Director of Regulatory Affairs

Our client, a leading medical device company, is currently recruiting a Director of Regulatory Affairs to provide leadership and energy to its regulatory affairs team. This is an exceptional opportunity to join a corporate culture known for its innovative and growth-oriented vision. Responsibilities include:

1) Direct and co-ordinate activities of Regulatory Affairs staff, including direct supervision of RA/QA associates and specialists and external contracted clinical CRO’s or regulatory consultants
2) Plan, budget, and implement regulatory strategies for new and modified devices
3) Establish department project priorities, and allocate resources and workload
4) Prepare timely submissions to the FDA and Health Canada and other regulatory agencies
5) Ensure consistency and quality of FDA and HC submissions/filings, through technical guidance to staff during the course of strategy formulation and document preparation
6) Prepare, review, edit and submit regulatory filings in accordance with FDA (including electronic requirements) and HC regulation
7) Advise senior management within FMSU of prevailing and evolving FDA and international regulatory requirements and environment
8) Act as company representative, developing and maintaining a positive relationship with FDA and HC through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up for submissions under review
9) Assist senior management in the initiation and management of clinical investigations
10) Oversee generation of investigational plans and monitoring, including statistical design
11) Co-ordinate qualification of all investigational centers
12) Direct analysis and reporting of data
13) Generate clinical study reports
14) Assist with co-ordination for training of physicians and other medical professionals in protocol requirements
15) Maintain controls needed to maintain compliance with good clinical practices
16) Interface and oversee contract research organizations
17) Review clinical publications to ensure that data is congruent with data collected by the company
18) Review and approve product and manufacturing changes for development projects to ensure adherence to quality system requirements and the impact on current investigations and applications
19) Co-ordinate with quality management on filing of customer complaints, CAPA’s and MDPR’s, and conduct field corrections/recalls in compliance with department and corporate (FTYO and FMSU) procedures
20) Review device labeling and advertising materials for compliance with US and international labeling regulations
21) Develop, implement and train employees of quality systems supporting development of products, including but not limited to design control
22) Comply with FMSU, FMSU ESD and FTYO quality manuals and policies/procedures, manage external regulatory audits (FDA, HC, ISO, etc.), execute internal quality system audits, and create and manage internal plans to improve the quality system in deficient areas
23) Participate in additional projects and assignments as required to continually improve the regulatory and quality system compliance in close coordination with FTYO colleagues and senior management

Critical Requirements:

1) A university degree is required (preference will be given to those with degrees in a relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people with recent experience in regulatory affairs

If you think you're a perfect match for this role, you could be just the person to fill the position. Please apply ASAP.