Regulatory Affairs Specialist

Modis söker nu en Regulatory Affairs specialist för ett konsultuppdrag på ett läkemedels/medtechföretag i Uppsala. Grundkrav är minst 4 års erfarenhet av regulatoriskt arbete och gärna med medical devices. Konsultuppdraget sträcker sig initialt i 6 månader och start är så snart som möjligt. Geografisk placering för bolaget är Uppsala men det skulle även vara möjligt att arbete på distans från andra delar av landet för rätt konsult.

Nedan följer en rollbeskrivning på engelska.

International Registrations: You will be responsible for registration activities related to new product development, new product introduction, renewals and post approval changes for Asia Pacific, Japan, Latin America and Europe, Middle East, and Africa. This individual will work closely with the regional leads and the Regulatory Operations team to ensure a clear understanding of the health authority (HA) requirements for each request/submission. This individual will be responsible for ensuring the required high-quality documentation is dispatched to the local teams for on-time HA submission per the agreed upon schedule. This individual will be responsible for ensuring on-going and frequent communication with the regional leads and key stakeholders. This individual may also be responsible for ensuring that any new external requirements (e.g. regulations, standards, etc.) are identified and assessed in a timely manner as well as any other sub-functional areas within the department as needed. You may be responsible for participating in audits related to international registrations.

Global Change Assessments: You will be responsible for managing the Global Change Notifications/Assessments for Surgical Vision´s Ophthalmic Viscoelastic Devices (OVDs). You will be responsible for ensuring all changes are properly assessed globally and in a timely manner. You will be responsible for participating in audits related to global changes.

The Regulatory Affairs Specialist II will participate on cross-functional teams as needed and provide project leadership on a worldwide basis to achieve desired outcomes within defined timeframes. This individual will assist in the development of best practices for RA processes, partners with other functions to define and obtain data to assist with regulatory submission.

Responsibilities:

• Ensures compliance with regulatory agency regulations and interpretations.

• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

• Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.

• Provides solutions to a variety of problems of moderate scope and complexity.

• Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates

• Provides regulatory guidance to product development teams and responds to product information requests

• Provide Regulatory Affairs support during internal and external audits

• Assists in the development of best practices for Regulatory Affairs processes

• Represents Regulatory Affairs on cross-functional project teams

• Adheres to environmental policy and procedures and supports department environmental objectives.

 

Qualifications and Experience:

• A minimum of a Bachelors degree with at least 4 years of working experience within a regulated environment or equivalent is required – preferable medical device.

• Excellent written, verbal communication and presentation skills is required.

• Knowledge of US and EU regulations is preferred.

• Experience in the preparation and submission of international regulatory filings is preferred.

• Previous experience working with cross functional teams within a matrix environment is required.

• Swedish speaking is preferred.

• Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products is preferred.

• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives is preferred.

• Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions is required.

• Provides support to projects of medium complexity and ensures timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance is required.

• Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.

• This role is to be based in Uppsala, Sweden and will require up to 10% domestic and/or international travel.