Posted:
6/27/2024, 5:00:00 PM
Location(s):
Województwo mazowieckie, Poland ⋅ Warszawa, Województwo mazowieckie, Poland
Experience Level(s):
Senior
Field(s):
Legal & Compliance
We are looking for a Senior Regulatory Affairs and Quality Assurance Specialist in Poland for a contract until the end of 2025. Based in Poland (Hybrid), you will be part of the RAQA team supporting Middle East and North Africa (MENA) :
What you will do :
Executes RA activities in line with defined procedures and processes.
Obtain product registration dossiers from EMEA Central RA and tailor them to meet country registration requirements
Communicate with Stryker consultants and distributors across MEA to track and ensure timely dossier submission to the relevant authority
Assist Stryker Customer Service team and local dealers in preparing country specific regulatory documentation for custom clearance in MEA (Middle East and Africa) region
Create and maintain registration database for MEA countries.
Implements processes involved with maintaining annual licenses, registrations, and listings
Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
Assesses regulatory intelligence to assist in the development of local and regional, regulatory strategies
Evaluates the country/region regulatory environment and contributes to providing internal advice throughout the product lifecycle to ensure product compliance
Report regulatory obstacles and emerging issues throughout the product lifecycle and propose solutions
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
Provide on the job training for new team members and delivers training to stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Performs based on established targets, KPIs and objectives for RAQA.
Provides support to EMEA / Country RAQA teams as appropriate.
What you need :
Minimum 2 years experience in Regulatory Affaires
Bachelor's/Master's degree
Experience in Medical Device or Pharmaceutical industry desired
Fluent in English
Strong IT skills, including Microsoft Office.
Ability to connect and relate well with people
Be active in preparation of briefings and other information documents.
Accountable for local process and training implementation
High attention to detail and process consciousness
Limited travel required to Stryker Dubai site or other Stryker sites for meetings.
Website: https://www.stryker.com/
Headquarter Location: Kalamazoo, Michigan, United States
Employee Count: 10001+
Year Founded: 1941
IPO Status: Public
Industries: Biotechnology ⋅ Health Care ⋅ Life Science ⋅ Medical ⋅ Medical Device