Principal Clinical and Regulatory Affairs Specialist

contract hire - Minneapolis, MN
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Principal Clinical and Regulatory Affairs Position

Contract Hire – Minneapolis, MN

The Principal Clinical and Regulatory Affairs Specialist is responsible for executing Clinical and Regulatory affairs activities in support of clients.  This role helps to identify and resolve problems, provides regulatory and clinical guidance to clients, and demonstrates strategic thinking and creativity in support of clients.  In addition, this position will be a key point of escalation in resolution of issues and risks, working closely with clients to ensure on time delivery.

Essential Duties and Responsibilities:

  •  Lead clinical study projects, collaborating with internal stakeholders to determine resources for study operations and execution, including data management and electronic data capture
  • Coordinate, write, review and/or submit Client regulatory submissions (including, but not limited to pre-submission meetings, IDEs, 510(k), and Technical Files, Design Dossiers, etc.)
  • Serve as Clinical Affairs, Regulatory Affairs, and EU MDR & MEDDEV Rev 4 CER regulations subject matter expert
  • Perform projects in compliance with regulations and client policies and procedures
  • Effectively manage time to support multiple projects and/or cross-functional projects
  • Participate in the planning and execution of client-specific strategic regulatory development plans for projects assigned
  • Perform gap assessments to EU MDR for Class IIa, IIb, and III files and provide remediation guidance to clients
  • Review and assess changes to the design, manufacturing, and labeling to determine impact to submissions and product safety and efficacy
  • Create letters to file as necessary
  • Perform remediation projects related to transition from EU MDD to EU MDR
  • Provide input into content and strategy for clinical study protocols
  • Ensures adherence to project budgets, time schedules, and scope of work
  • Work outside the organization to network and promote consulting company
  • Other duties as assigned

Qualifications:

 

  • Advanced Degree in biological or medical science is required or equivalent education and experience with demonstrated ability to perform the essential functions of the job may be considered
  • Minimum 8 years Regulatory Affairs experience within the medical device industry
  • Minimum 6 years Clinical Services experience within the medical device industry
  • Expertise with current regulatory agency guidance and regulations, including EU MDR and MEDDEV Rev 4, Health Canada, ISO 14971 and 13485, MDSAP, FDA 21 CFR 11 812, 814, and 820, 510(k) regulations
  • Possesses a deep understanding of EU MDR and MEDDEV Rev 4 CER regulations
  • Working knowledge of regulatory submissions to various international health authorities is a plus (including but not limited to China, Japan, Canada, EMA, Australia)
  • Expert knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states
  • Demonstrated ability to critique clinical, regulatory, and quality documentation
  • Excellent communication and interpersonal skills, ability to establish and maintain effective communication with colleagues and clients
  • Expert knowledge of design control process, clinical evaluation reports, post-market surveillance, and periodic safety update reports
  • Proficient in word processing tools, spreadsheets, and/or database applications (e.g., MS Word and Excel, EndNote or comparable citation manager and PerfectIt software)
  • Excellent time management skills
  • Demonstrated ability to work remotely
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