Regulatory Affairs Specialist - Denver, United States - Primary Talent Partners
Description
Primary Talent Partners has a 12 month contract opening for a Regulatory Affairs Specialist (MDR) with a Medical Device client of ours.
Pay Rate:
$40 to $55 per hour
Work Location:
Can be remote, prefer candidates within Colorado if available
Top 3 Skills:
Detail-oriented for review of product changes and documentation review, including labeling
Prior experience authoring EU MDR Technical documentation and managing review with notified body
Experience routing documents and changes through a controlled document control system
Must Have:
1) Understanding of EU MDR regulation and remediation needs;
2) strong technical writing EU MDR Remediation
Overview:
Engage with cross-functional team focused on MDR product remediation and/or implementation to establish global regulatory strategies, participate in creation and review of key product development deliverables and author regulatory documents (EU MDR Technical Documents).
Provide support to transition currently marketed products from EU MDD to EU MDR, including review of product/ manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.
Education:
Bachelors in a scientific or technical discipline, engineering is preferred.
Years Experience Required:
Minimum of 3 years with advanced degree and Minimum of 5 years with a bachelors degree
Responsibilities:
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.
The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS
Autonomy:
Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact:
Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
Innovation and Complexity:
Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.Communication and Influence:
Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.
Leadership and Talent Management:
May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at#PTPJobs
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