Develop and execute Global Regulatory Strategies and
Plans to assure that new Infusion Systems products and changes to existingproducts are developed in line with the global registration requirements oftargeted countries. Develop high quality US and global regulatory submissionsthat continue to build credibility with regulatory authorities. Obtainexpedient registration for assigned products. Maintain registrations of existing products in compliance withapplicable regulations
Essential Duties &Responsibilities
Develops regulatory strategies for development projects, design changes and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by global regulatory authorities.
Acts as Global Regulatory Affairs Lead on the cross functional teams developing and executing regulatory strategies, communicating regulatory requirements and ensuring they are incorporated into program deliverables
Manages the preparation of global registration packages and responses to requests for additional information. Negotiates submission data requirements and deliverable dates with internal technical teams. Author with team members, regulatory submissions for the software driven medication delivery systems.
Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products.
Work with region and country RA counterparts to evaluate changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations.
Accurately describes these changes for ease of regulatory agency review.
Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
Reviewand approve critical documents, seeking guidance when necessary.
Reviewtechnical reports and determine acceptability for regulatory submission.
Analyzes and interprets complex scientific data as well as global regulations.
Assesses scientific data provided for registration purposes to ensure it meets regulatory requirements.
Identifies gaps in product submission and executes plans to mitigate the risk to approval.
Summarizescomplex technical data.
Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues.
Presents scientific data effectively orally and in writing in a logical and persuasive manner.
Independentlyprovides daily regulatory support to new global product development teams andfor maintenance of commercial products.
Hasthe authority to prepare and submit complex regulatory submissions.
Directssubmission related activities by leading the team and motivating the staff tosuccessfully execute regulatory strategies.
Makesindependent judgments and decisions based on regulations and professionalexperience. Ensures alignment with
Regulatory Management as appropriate.
Reviewsregulatory commitments, strategy decisions, meeting strategies with regulatoryauthorities and changes to resource allocations with manager prior toexecution.
If responsibilities include people management, makes independent personnel decisions.
Knowledge,Skills & Qualifications
Abilityto manage multiple assignments, makes timely decisions, communicates concernsand self-motivated
Astutemanager and collaborative team leader. Able to establish clear objectives, planand organize work flow, etc., and bring right balance of leading by example andexerting influence to
Overall,brings a creative mind-set and innovative approach
Excellent oral and written communicationskills.
Excellent interpersonal skills.
Well-developed negotiating skills. Strongunderstanding of business needs
Proficiencyin Microsoft office including Word, Excel, Power Point and Outlook
Bachelor's Degree in related field required,Master's degree is preferred. R. Ph is a plus. A degree or experience inEngineering, Regulatory affairs or a related field
Ability to provide guidance to technicalteams, technical writing, and in problem solving technical issues as theyrelate to product development, manufacture and global registrations.
Proven strong record of preparing 510Ksubmissions and obtaining clearances in their name.
Advanced experience with assembling globaldossiers
Minimum of four years' experience inregulatory affairs to include drafting 510(k) or CE technical files.
Well-developed Experience working directlywith regulatory agencies. Soundknowledge of applicable portions of agency regulations and applicable guidancedocuments.
Must be atleast 18 years of age
Must passpre-employment drug screen and background check
Physical Requirements and Work Environment
This is largely a sedentary role.
This job operates in a professionaloffice environment and routinely uses standard office equipment.
Physical Requirements and Work Environment
We are an Equal Employment Opportunity Employer,Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.