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Specialist II, Reg Affairs

Company:
Boston Scientific Corporation
Location:
Cork, Country: Ireland
Job Type:
Job Description

Additional Locations:

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

Purpose:

Responsible for Regulatory Affairs support of the site, submissions and regulatory compliance.

Responsibilities:

  • Working as part of a team responsible for Regulatory Activities and issues occurring at Boston Scientific. Includes review/maintenance of Technical Files and providing information to US/ International Regulatory Affairs groups for other submission activities as well as regulatory issues relating to labeling, product releases and change requests.
  • Assist in preparation of Design Dossiers/Technical Files for all site products, in conjunction with divisional RA personnel and site QA personnel.
  • Convert MDD Regulatory files to EU MDR 2017/745 regulations requirements.
  • Review and approve documentation related to product release/changes through the CR process.
  • Provide input, review and approve facility regulatory activities such as labelling.
  • Provide Emerging Markets submission information to U.S. based and Emerging Markets based International Regulatory Affairs personnel for site products.
  • Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
  • Support the QA function during external agency audits.

Experience & Key Requirements

  • Minimum qualification required: BSC/BEng degree.
  • Regulatory experience preferred but not essential
  • Minimum 3 years experience in a Health Care environment in a technical function
  • Experience in MDD ,FDA, ISO, environment
  • Strong team member with the ability to identify and drive regulatory compliance improvements
  • Good administrative/organizational ability with excellent attention to detail.
  • Technical writing ability.
  • Excellent communication skills
  • Excellent analytical/decision making skills

We are committed to providing access to opportunities at Boston Scientific for all applicants. If you have a disability and require supported assistance and you would like to talk about potential accommodations related to applying for employment at Boston Scientific Cork, please contact me directly for a confidential discussion corkrequisitions@bsci.com . Tel No: 021-4531182.

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Requisition ID: 468501


Job Segment: Medical, Law, Medical Technology, Compliance, Healthcare, Legal, Quality

Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Boston Scientific Corporation
Company size: 1-49
Contact: NA