Job Description

Job Description

Job Description

Job Title: Sr Regulatory Affairs Specialists

Job Location: Waltham, MA, USA

Job Location Type: Remote

Job Contract Type: Part-time

Job Seniority Level: Mid-Senior level

A Senior Regulatory Affairs Specialists job in Mounds View, MN is available through IntePros . Candidates will be responsible for directing or performing coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. This will also include taking lead or compile all materials required in submissions, license renewal and annual registrations. Candidates will also be responsible for recommending changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance, as well as monitoring and improving tracking / control systems, and staying abreast of regulatory procedures and changes.

This a two-year contract assignment.

This is a part-time position.

This is a Hybrid opportunity that can be fully remote.

This position will pay up to $73 hr D.O.Q.

Senior Regulatory Affairs Specialists Job Responsibilities Include

• 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.
• Delivering and overseeing the projects from design to implementation while and adhering to policies .
• Coaches and reviews the work of lower level specialists; may manage projects / processes.
• Works independently under limited supervision to determine and develop approach to solutions.
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. (May be responsible for entire projects or processes within job area. )
• Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Communicates with senior internal and external customers and vendors.
• Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
• May provide guidance, coaching and training to other employees within job area.
• May manage projects, requiring delegation of work and review of others work product.

Qualifications

• Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Must have experience ISO 13485.
• Must have experience with 21 CFR part 820, 821, and EU 2017/745.
• Must have experience with 30 day, and 510k compiling.
• Must have experience with CAPA, PFMEA and FMEA.

If you are interested in this Senior Regulatory Affairs Specialists job in Mounds View, MN then please click APPLY NOW. For other opportunities available at IntePros go to .If you have questions about the please contact Robert Schemel .

Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

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Job Tags

Contract work, Part time, Remote job,

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