Senior Regulatory Affairs Specialist
- Define global regulatory pathways for projects across the EU, US and elsewhere internationally with regard to product launches and changes.
- Prepare for regulatory submissions such as FDA, Notified Bodies, Health Canada and other regulatory authorities
- Work together with international regulatory agencies on products and projects, answering any relevant questions on issues with products and change controls.
- Provide support for commercialized products by reviewing labelling, promotional materials, and product and documentation changes per policy and procedure.
- Work cross functionally internally providing technical guidance and regulatory mentoring to Design Assurance, Quality and Manufacturing teams.
- Participate and assist with FDA facility inspections, Notified Audits and other Governmental inspections.
- Bachelor’s degree in STEM related field with working knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), the Medical Device Regulation (2017/745, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485 and MDSAP.
- 4 or more years’ experience in regulatory affairs or related type positions.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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