Engineering Project Manager, EU Regulatory Pharma at HAYS in Skaneateles, New York

Job Description:

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.


The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.


Our client is seeking an Engineering Project Manager, EU Regulatory Pharma, for a remote opportunity.


Role Description


Program Manager to lead the activities to ensure compliant EU MDR Technical File submissions of on market Baxter Front Line Care (FLC) Products. The Program will address multiple projects/submissions across the Front Line Care Portfolio. Responsible for managing overall execution and communication between the individual Project teams, key stakeholders, and leadership.


• Coordinates work performed within multiple functions including R&D, Packaging, Operations, Regulatory and Quality by facilitating project scope definition, managing budget, and monitoring risk on a program level scale.


• Supports team by assessing and managing resource allocation, progress tracking and facilitating budget and schedule changes through the change control process.


• Ensures adherence to quality standards and reviews project deliverables with stakeholders.


• Manages vendor partners, provides guidance to project team, provides senior leadership with status updates.


• Strong partner with Regulatory leadership and Certificate Strategy team to ensure successful certifications for all in scope products.


• Responsible for managing team of contract project managers who lead the individual projects under the program.


Skills & Requirements


• Good communication and organizational skills required.


• Must have previous experience as a project manager in medical device field for a minimum of 5 yrs.


• Experience with EU regulatory systems and requirements as well as technical knowledge of operations execution


• PMP Certification preferred.


• Excellent analytical and pragmatic problem-solving skills.


• Ability to provide strategic advice as well as operational solutions.


• Strong interpersonal skills with the ability to influence and communicate with individuals at all levels in an organization.


• Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives.


• Track record in providing high degree of reliance, accountability, and value-added consultation/support to business managers and other support functions.


• Bachelor's Degree or local equivalent of same; generally, 8-11 years of experience (minimum 5).


Benefits/Other Compensation


This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).


Why Hays?


You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.


Nervous about an upcoming interview? Unsure how to write a new resume?


Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.


Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.


In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.


Drug testing may be required; please contact a recruiter for more information.


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#1159535 - Laurie McComb