Regulatory Affairs Manager

HERO

Job Detail

Location Ireland
Salary Negotiable
Posted
Role Type Permanent
Contact Mark Wilson
email talent@hero.ie

Regulatory Affairs Manager

Apply Now

Job ID: JOB-12879

Regulatory Affairs Manager – Remote position- Ireland

We know it’s not all about the money when you’re looking for your next Reg Affairs Job job but we also know it’s important too! HERO are working with a global leader in MEDICAL DEVICES to find the very best of talent for their operation. Why should you apply?  This Regulatory Affairs job opportunity offers exceptional career development opportunities whilst delivering excellent salary and benefits package. 

Let’s talk to see if this is the right move for you.

Key Responsibilities

  • Oversee team’s area of responsibility, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports.
  • Provide direction, leadership and coaching to staff to meet schedules, resolve technical or operational problems. Becomes actively involved in daily operations to meet schedules or to resolve complex problems. 
  • Keep Senior Management informed of regulatory status of products and significant regulatory issues. 
  • Collaborate with cross-functional peers to achieve business objectives.
  • Direct interaction with regulatory agencies on defined matters.
  • Maintain proficiency on regulatory requirements.
  • Accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives.
  • Recruit, develop and retain talent.  

Must Have: Minimum Requirements 

  • Level 8 Degree in Scientific or Engineering field.
  • Minimum 7 years’ experience in regulatory affairs for medical devices of which 3+ years had leadership experience as demonstrated through direct management and/or mentorship/advisory capacity.
  • OR PhD with a minimum 5 years’ in in regulatory affairs for medical devices of which 3+ years had leadership experience as demonstrated through direct management and/or mentorship/advisory capacity. 
  • Candidates with experience in quality, R&D, or engineering for medical devices and with relevant experience may also be considered for the role 

Nice to have:

  •   Understanding of engineering concepts and scientific terminology; experience with       vascular therapies preferred.

    •    Solid understanding of manufacturing and change control, and an awareness of regulatory trends.

    •    Experience interfacing with regulatory agencies.

    •    Ability to flex and adapt to changing priorities.

    •    Ability to handle advanced concepts and undefined paths.

    •    Effective oral and written communication skills.

    •    Ability to recognize and develop key talent.

    •    Ability to travel approximately 20%.

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

 

Mark Wilson

JOB-12879

Apply Now

Regulatory Affairs Manager

Mark Wilson

Role Type Permanent
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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