Regulatory Specialist II

1 month ago

Scarborough, United States DivIHN Integration Full time

DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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Please apply or call one of us to learn more

For further inquiries regarding the following opportunity, please contact one of our Talent Specialist

Rashi

Title: Regulatory Specialist II

Location: Scarborough, ME

Duration: 7 months

Start Time (AM/PM) : 8am - 5pm

End Time (AM/PM) : Monday - Friday

Description:

  • In this role you will prepare documentation for EU Technical Files and international product registrations.
  • This job description will be reviewed periodically and is subject to change by management.

Exempt/Non Exempt:

  • Non Exempt

Years Experience:

  • 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

Skills:

  • Knowledge of regulations and standards affecting IVDs and/or biologics

Education:

  • BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

Duties:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides consultation/advice to regulatory specialist for change control and product development.
  • Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
  • Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
  • Handles regulatory activities involved in documentation,labeling,field support.
  • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

RESPONSIBILITIES:

  • Responsible for technical writing of files in accordance with In Vitro Diagnostic medical
  • device Regulation (IVDR).
  • Provides regulatory support for diagnostic product development and commercial
  • diagnostic products.
  • Develops regulatory strategies for products in development and for modified products to
  • achieve clearance/approval in the EU and internationally.
  • Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
  • Researches and communicates scientific and regulatory information in order to write submission documents.
  • Compiles and publishes all material required for submissions, license renewals, and annual registrations.
  • Maintains approvals/licenses/authorizations for existing marketing authorizations.
  • Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
  • Develops internal procedures and tools.
  • Conducts informational or training sessions for stakeholders.
  • Organizes and maintains hard copy and electronic department files.
  • Demonstrates commitment to the development, implementation and effectiveness of client Quality Management System per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

BASIC QUALIFICATIONS EDUCATION:

  • Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
  • 4 years' experience in Regulatory Affairs role.
  • Strong knowledge of IVDR and EU regulatory requirements is required.

PREFERRED QUALIFICATIONS:

  • 1 years' experience in an IVD or medical device manufacturing environment.

COMPETENCIES:

  • Good knowledge of EU and international regulations.
  • Demonstrated written and verbal communication skills.
  • Strong time management skills, with the ability to work on multiple projects simultaneously.
  • Ability to work independently as well as within a team.
  • Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio

Notes

  • Looking for someone with IVDR experience - familiar with requirements, tech files, documentation support.
  • Regarding European market, this is the designation needed in order to be able to legally sell their products in Europe.
  • Presently the rules are more stringent, and they have implemented more rigorous regulations and review. This position will be working with the team to make sure (products from client) everything is in compliance
  • Ideal candidate must be able to hit the ground running.
  • Re: Education, At least a Bachelor's degree. Scientific background preferred.
  • Experience - Ideal is 3-4 years plus of work exp (definitely need experience with IVDR)
  • Cross functional, quality, randd to aid in the writing and compilation of these docs.
  • Environment - Working with the Regulatory Team in SCR- small, team of 4 ppl.
  • Travel: No travel
  • Would they entertain any non IVDR exp candidates - Probably not as the candidate would need that experience to do this job.
  • Would 3 yrs of experience as well be considered-Yes
  • What are some soft skills that would be needed?
  • A person who can work independently if needed but also works well on a team. Self-directed.
  • Attention to details, meticulous documentation capability. Able to read and understand regulatory issues, technical jargon.

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

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