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Senior Regulatory Affairs Specialist

Manufacturing / Production
Cork
Danielle Francois
Permanent
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Job Reference: JO-2103-65694_1631611955

Summary:

My client is a leading medical device manufacturer within the ophthalmic industry, and I am currently partnering with them to identify an experienced Senior Regulatory Affairs professional. This role will make an essential contribution to the team and lead regulatory strategies for Cork-based projects and will be responsible for continuous improvement initiatives as well as supporting and leading the submission process. This role can be mainly based from home but will require an onsite presence from time to time,

Responsibilities:

  • Key member of the New Product Introduction projects to ensure alignment with corporate commercialization strategies
  • Lead Product Support member to ensure documented continued device compliance to applicable market regulatory requirements.
  • Review and approve product labelling materials for compliance with applicable regulations and standards.
  • Participate in internal and external company regulatory /quality audits
  • Lead RA representative for site change management with input into RA metric reporting
  • Maintain currency and accuracy of CE Technical Files aligned with device and process changes
  • Prepare regulatory dossiers for submission to Health Authorities and maintain them along with the whole product life cycle
  • Monitor global market regulatory changes, advise and/ or implement changes to ensure compliance.
  • Involvement in the general activities within the department, including improving and implementing integrated regulatory business processes.
  • Interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements
  • Ensure continual Quality System compliance by adherence to established and evolving QS requirements.

Education & Experience

  • Degree in an Engineering or Science discipline
  • 7 years experience in an RA role within an FDA and/or ISO 13485 regulated medical device environment. Strong QA experience will also be considered
  • Ability to lead teams
  • Flexible with the ability to adjust to changes in schedule, priorities
  • Must be articulate and able to communicate effectively with associates at all levels of the organization
  • Demonstrated excellent attention to detail
  • Excellent time management skills and proven ability to meet tight deadlines and ability to work under pressure
  • Thrive in a fast-paced work environment while possessing the ability to quickly change priorities and perform multiple tasks simultaneously
  • Pro-active with proven ability to work under own initiative, problem solve and be a strong team player
  • Ability to work on diverse project teams to provide Regulatory expertise and leadership.
  • Proven track record in writing Regulatory medical device submissions

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Danielle Francois
Danielle Francois
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