Job Description
The Manager, Global Regulatory Affairs, is responsible for defining and implementing global regulatory strategies and submissions in support of new and existing marketing authorizations for electromechanical and software medical devices supporting the Infusions Systems, Medication Delivery Business Unit. The position will represent Global Regulatory Affairs on cross-functional project teams, and ensure alignment with business goals for projects. The position is responsible for US submissions (510(k)s/PMAs/IDEs) and regulatory submission compliance for assigned products. Responsibilities also include leading interactions with international regulatory colleagues to ensure appropriate communication and alignment to support global requirements and device submissions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/ authorizations for existing marketing authorizations.
Represent or lead the RA function on assigned cross-functional project teams supporting electromechanical and software medical devices in the Infusion Systems business unit.
Monitor applicable regulatory requirements; assure compliance with external standards.
Manage and resolve submission issues. Advise on issues of product/process quality and risk assessment.
Establish appropriate communication within RA and other functions primarily at project level.
Develop and document sound regulatory decisions and justifications.
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
May review promotional material or SOP’s for compliance with local and global regulations.
QUALIFICATIONS
Sound basis of regulatory knowledge. Specific knowledge of regulatory expectations for software driven medical devices.
Scientific knowledge and thorough understanding of medical device development with a strong emphasis and experience in the hardware and software area. Ability to foster a high degree of scientific credibility with regulatory authorities.
Proven ability to prepare device applications for the US (i.e. IDEs, 510(k)s, PMAs).
Ability to manage complex projects and timelines in a matrix team environment
Strong oral and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
EDUCATION AND EXPERIENCE Bachelor’s degree in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects. Higher degree/PhD will be an advantage.
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