Duration: 12+ month contract
Location: Deerfield, IL 60015
Could work Remote
Overview: I am currently looking for a Remote Medical Device Regulatory Project Manager for one of our clients in the Deerfield area. The CRS Group is a nationwide Staffing Firm who works primarily with Fortune 500 and Fortune 1000 corporations.
The healthcare industry requires that we abide by medical device regulations from around the world. Part of the requirements is to produce documents which describe the safety and performance of our medical devices. We are looking for individuals to manage the execution and successful completion of document deliverables to ensure required timelines are met. The ideal candidates must have project management experience, be fluent in English (both writing and speaking) and possess critical thinking and analysis skills.
Duties and Responsibilities:
- Facilitates communication between the WWM-S&D Team, Subject Matter Experts (SMEs), and the Medical Writer (internal or external vendor) to ensure on-time delivery of high-quality regulatory documents for medical devices, Risk Class I through III.
- These regulatory documents include: Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up Plans and Reports (PMCFPs, PMCFRs), and Summary of Safety & Clinical Performance (SSCPs).
- Manages the successful completion of deliverables for regularly scheduled updates (On-Cycle Periodic Review/Updates) as well as ad-hoc updates (Off-Cycle Updates)
- Develops deliverable project plans/schedules; working closely with the Master Schedule Manager and Medical Writer to ensure timelines are met.
- Schedules deliverable kick-off meetings to confirm deliverable scope, project schedule, assigned SMEs, and availability of source documents.
- Ultimately responsible to drive the effort in successfully delivering the required documents by the required timelines.
- If anything places that delivery at risk, collaborates with cross functional business partners to mitigate that risk.
- Owns the historical context of each of the deliverables including why historical decisions were made around each of the assigned deliverables.
- Communicates this context during the next document update and ensures the correct decisions are made based on this history.
- Proactively partners with cross functional business partners (i.e., SMEs) such as WWM-Medical Affairs, Post Market Surveillance (PMS), Quality, Research & Development (R&D), Regulatory Affairs (RA), and potentially external vendors.
- Collaborates with Medical writers and ensures all source documents are obtained timely from Team Center Database or SMEs.
- If vendor is not contracted to provide this data gathering scope, Deliverable PM will gather the source documents.
- Implements an effective communication model with cross functional team members that provides deliverable status updates and supports timely completion of deliverables.
- Anticipates potential deliverable schedule conflicts and challenges for proactive solutions and manages deliverable schedule for win-win results.
- Ensures escalation of risk management response strategies to leadership within WWM, as well as SME Leadership Team.
- May participate in workshops and company initiatives to help define processes globally and to provide best practices for continuous process improvement.
- Expertise in project management
- At least 3 years of on-the-job project management experience required
- R&D background a plus
- Being able to work with 5-8 teams with the same goal
- Keep teams on time schedules
- Excellent oral and written communication skills
- Strong organizational skills, attention to detail, and business acumen
- Must possess knowledge and expertise in Microsoft Word, Microsoft Excel, Microsoft Project and Adobe Acrobat products. Knowledge in Microsoft Visio is a plus.
- Must have a flexible mindset, able to work in a fast-changing environment with competing priorities
- Able to problem solve and resolve issues/obstacles to successfully meet deliverable timelines
- Proven ability to work collaboratively with cross functional teams to meet timelines where competing priorities may exist
- PMI or IPMA or equivalent certification preferred
- Experience within the medical device industry preferred
- Minimum of a Bachelor’s degree (discipline: Business, Sciences)