$150K — $200K *
The Regulatory Affairs Manager will focus on the execution of strategic regulatory projects for Teleflex diagnostics products. This role will be responsible for management of global regulatory affairs activities related to the implementation of strategic projects which include a broad set of activities as described below.
This role is responsible for partnering with cross-functional partners to maintain a scalable, strategically appropriate and maintainable regulatory affairs program for the products. This role supports the Global RA/QA teams in Corporate and other projects/initiatives.
• Represent the Regulatory Affairs function at the leadership level.
• Build, develop and oversee the regulatory affairs team, creating and maintaining a functional RA team structure that can effectively and efficiently support the needs of the business.
• Provide guidance and training on regulations, strategic regulatory planning, and regulatory support of quality initiatives.
• Management and development of staff. Ensure that regulatory positions are staffed with qualified, motivated employees. Ensure that reports are appropriately trained and have the resources necessary to do their assigned jobs. Provide reports with career development opportunity and help them to realize their career goals.
• Provide direction and leadership with respect to regulatory strategy and execution.
• Partner with corporate RA to ensure that products are registered in foreign markets. Develop appropriate systems and methods to facilitate global registration.
• Liaise closely with R&D, marketing, clinical and QE/QA teams to ensure a clear understanding of regulatory requirements and understand the needs of these functions to achieve the most prudent path to market.
• Oversee activities required to obtain market authorizations in the US, EU and Canada including development of regulatory strategies, appropriate market authorization pathways, agency meetings, clinical study determinations, and creation of the required documentation (internal and external).
• Facilitate communications with regulatory agencies, as needed, to obtain input and guidance on market authorization pathways, product development inputs, etc.
• Analyze worldwide regulatory requirements for new or significantly changed products and author any necessary marketing approvals.
• Other miscellaneous regulatory activities such as providing regulatory input to support new product development, labeling and promotional materials review and product testing related to regulatory approvals and modification assessment.
• Partner with business constituents to assure all marketing plans are understood and the necessary regulatory product approvals are received in a timely fashion.
• Partner with QA where regulatory input is required (e.g. audits, CAPA/NC investigations).
• Create regulatory policies, procedures and other quality system documentation as required.
• Assure compliance to applicable import and export regulations.
• Submit and champion applicable Investigational Device Exemptions through US and Foreign Governments.
• Communicate the changing global landscape of regulatory requirements to the rest of the organization.
• Maintain strong relationships with US and International Regulatory Agencies.
• Perform regulatory due diligence to support M&A projects.
Education / Experience Requirements
• B.S. Degree with 10 or more years of medical device regulatory affairs experience, and prior leadership of teams of 4-10 regulatory affairs professionals.
• Broad regulatory knowledge base including global requirements for: marketing approvals, change assessment; complaint handling; adverse event reports; recalls; labeling; and quality systems.
• Regulatory certifications preferred, e.g., RAC, CQA, CQE, CQM
• Proven experience working with FDA and/or EC Notified Bodies, HPRA (IE), MHRA (UK) or other.
• Proven experience with 510(k)’s, technical files and Canadian device licenses.
Valid through: 12/7/2020
$80K — $120K
2 days ago