Principal Regulatory Consultant

Location: St. Louis Park, Minnesota
Requisition Number: 2267
# of openings: 1

Description

NAMSA is a global medical device research organization providing a comprehensive range of services to prove efficacy, non-clinical and clinical safety of medical devices, IVDs, HCT/P and combination products. NAMSA has breadth and depth in consulting, non-clinical and clinical services with expertise in cardiovascular, orthopedic, ocular, neurologic, gastroenterologic, urologic, combination product and related medical devices.   For more than 50 years, NAMSA clients utilize its testing and consulting services to bring safe and effective products to market.

Principal Duties and Responsibilities

Regulatory Consultant

  • Develop positive relationships with clients, as well as with NAMSA colleagues.
  • Ensure that products and deliverables are of high quality given time and budget constraints.
  • Function at a level that affords respect by internal NAMSA Associates/team members.
  • Communicate project/team issues to Project Manager and /or Manager.
  • Function as a productive project team member.
  • Perform project in compliance with regulations and NAMSA policies and procedures.
  • Establish and ensure schedule, budget and quality commitments are met for the client.
  • Manage (motivate, communicate) internal team members.
  • Understand investigational product(s) and high level understanding of the Medical Device Development Process.
  • Handle challenging and/or novel situations. Uses judgment to determine when issues should be escalated.
  • Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
  • Deliver presentations, including preparation of slides, and speaking.

Senior Regulatory Consultant

In addition to the items listed above:

  • Effectively manage time to support multiple projects and/or cross-functional projects
  • Perform with accuracy and a high attention to detail

Principal and Senior Principal Regulatory Consultant

In addition to the items listed above:

  • Propose and implement systems to support internal improvement and NAMSA’s long-term growth.

 

Marketing Duties and Responsibilities

Regulatory Consultant and Senior Regulatory Consultant

  • Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.
  • Actively participate and lead meetings with prospective clients.
  • Obtain required scope of work to support creation of proposals.

 

Principal and Senior Principal Regulatory Consultant

In addition to the items listed above:

  • Conduct training and/or seminars for clients on current and forthcoming regulatory topics.

 

Role-Specific Duties and Responsibilities   

Regulatory Consultant

  • Coordinate, write, review and/or submit regulatory submissions (including but not limited to pre-submission meetings, IDEs, 510(k), and Technical Files, Design Dossiers, etc.).
  • Write, review, and assess test protocols and reports.
  • Coordinate, write and review regulatory assessments.
  • Assist clients in identifying required pre-clinical testing.
  • Perform literature reviews.
  • Develop regulatory strategies and participate in domestic (consultant’s home region) regulatory agency meetings with clients.
  • Identify and interpret Standards and Guidance Documents applicable to medical devices.
  • Able to professionally interact directly with government entities (e.g. FDA, notified bodies, etc.) on regulatory filings.
  • Current, working knowledge of medical device regulations and/or biologics regulations, i.e. US FDA 21 CFR, European regulations (i.e. MDD/MDR), Health Canada, 21 CFR 820, ISO 13485, MDSAP, NMPA, MHLW, any other global regulations and standards as relates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
  • Ability to assess regulatory impact of design and/or manufacturing changes.
  • Draft and/or evaluate regulatory SOP’s and WI’s.
  • Prepare white papers detailing current Regulatory topics.
  • Research laws and regulations for international countries, as needed.

Senior Regulatory Consultant

In addition to the items listed above:

  • Serve as an expert and able to professionally negotiate strategies directly with domestic government entities (e.g. FDA, notified bodies, NMPA, MHLW etc.) on regulatory filings at the reviewer level.
  • Function as an expert in International medical device regulations, combination product regulations and/or biologics regulations, i.e. US FDA 21 CFR, European regulations (i.e. MDD/MDR), Health Canada, 21 CFR 820, ISO 13485, MDSAP, NMPA, MHLW, other global regulations and standards as relates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
  • Work with client and/or test houses to develop pre-clinical test plans/protocols.
  • Develop animal study protocols in conjunction with client and animal lab personnel.

Principal and Senior Principal Regulatory Consultant

In addition to the items listed above:

  • Develop global regulatory strategy for medical device products.
  • Serve as senior expert and lead meetings with global regulatory agencies.

Qualifications and Skills

Regulatory Consultant

Requires a minimum of

  • Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience or Advanced Degree (Masters or PHD) and a minimum of 1 years of relevant experience; and
  • Regulatory experience in the medical device industry.
  • Strong written, verbal communication and interpersonal skills.
  • Problem solving and/or troubleshooting experience.
  • Project management experience, a plus.
  • Fluency in English and local language, if different, required.

Senior Regulatory Consultant

Requires a minimum of

  • Bachelor’s degree or equivalent experience in a related field, with a minimum of 7 years of relevant experience or Advanced Degree (Masters or PHD) and a minimum of 2 years of relevant experience; and
  • Regulatory experience in the medical device industry, both US and international.
  • Strong written, verbal communication and interpersonal skills.
  • Problem solving and/or troubleshooting experience.
  • Project management experience.
  • Fluency in English and local language, if different, required.

Principal Regulatory Consultant

Requires a minimum of

  • Bachelor’s degree or equivalent experience in a related field, 10+ years of relevant experience or Advanced Degree (Masters or PHD) and a minimum of 5 years of relevant experience; and
  • Regulatory experience in the medical device industry, both US and international.
  • Strong written, verbal communication and interpersonal skills.
  • Problem solving and/or troubleshooting experience.
  • Project management experience.
  • Fluency in English and local language, if different, required.

Senior Principal Regulatory Consultant

Requires a minimum of

  • Bachelor’s degree or equivalent experience in a related field, 15+ years of relevant experience or Advanced Degree (Masters or PHD) and a minimum of 10 years of relevant experience; and
  • Regulatory experience in the medical device industry, both US and international.
  • Strong written, verbal communication and interpersonal skills.
  • Problem solving and/or troubleshooting experience.
  • Project management experience.
  • Fluency in English and local language, if different, required.

Technical Competencies

  • Knowledge of and experience with Microsoft Word
  • Write and review complex documents

NAMSA is committed to providing equal employment opportunities (EEO) and treatment for every person seeking employment with or employed by our company.   The Company will not fail or refuse to hire any individual, discharge any individual, or otherwise discriminate against any individual by reason of a person’s race, color, creed, religion, national origin, sex, disability, age, citizenship, veteran status, genetic information, sexual orientation, marital status, gender identity, or status with regard to public assistance or any other characteristic, status, or condition protected by law.   Employment decisions are based solely upon qualifications and merit.  We recognize that diversity and inclusion is a driving force in the success of our company





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