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Remote MDR - Prin Regulatory Affairs Spec

New Brighton, MN 55112

Posted: 10/02/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614258 Is job remote?: Yes Country: United States

Job Description


Top 3 things the manager is looking for: 
  1. 1.EU MDR Experience
  2. 2.US FDA 510(k) Experience
  3. Change control experience

Top 3 Tasks or Responsibilities in scope for this role:
  1. 1.EU MDR Technical Documentation completion in addition to supporting responding to Notified Body questions (Working with a cross functional team)
  2. Supporting implementation of MDR CE Marked products
  3. Drafting 510(k)s to be submitted to FDA regarding changes driven by MDR


Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. 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: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About New Brighton, MN

Discover exciting job opportunities in the vibrant area surrounding New Brighton, Minnesota! Nestled in the Land of 10,000 Lakes, this charming city offers a perfect blend of small-town charm and big-city amenities. With its close proximity to the Twin Cities, job seekers can enjoy a plethora of career growth opportunities while savoring the unique culture and picturesque beauty of the region. Explore local landmarks like Long Lake Regional Park, catch a show at the historic Mounds Theatre, or cheer on the Minnesota Twins at Target Field. Don't miss out on the delectable cuisine, art galleries, and outdoor recreation this area has to offer. Take the next step in your career journey and browse our job listings in New Brighton, MN today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.