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Vacancy Details

Engineering & Technical

Regulatory Affairs Manager - Permanent - Galway - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 28/05/2019
Job Reference: 104200
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Regulatory Affairs Manager

We are seeking applications from a suitably qualified and experienced Regulatory Affairs Manager for a permanent position for our client, a medical device company in Galway.

Purpose Statement

Responsible for multiple product lines, technologies and specialized functions. Devotes a significant portion of time to managerial, leadership and employee development responsibilities.

Key Responsibilities:
  • Manage domestic and international regulatory activities and issues, including compiling submissions for US, EU and International approvals for Class III and other devices. Taking responsibility for regulatory activities related to new product manufacturing and market introduction, as well as regulatory issues relating to labeling, releases, and change orders.
  • Manage departmental procedure development and implementation.
  • Preview device labeling, product and manufacturing changes for compliance and applicable regulations.
  • Provide regulatory strategies for new product introduction.
  • Manage regulatory activities in maintaining regulatory compliance status of products in commercial distribution.
  • Manage interactions and relationships with external regulatory bodies on behalf of the company in relation to product approvals and post market compliance
  • Provide updates on regulatory requirement changes, either on individual product specification or quality systems and manage regulatory aspects on implementation of new regulations or requirements
  • Interface with divisional regulatory colleagues on regulatory matters relating to new product submissions or management of changes to existing devices.
  • Assist in the preparation and the management of regulatory and quality system audits.
  • Contribute to the quality and regulatory team process
  • Strong team member with the ability to identify and drive quality and compliance improvements.
  • Good administrative / organisational ability with attention to detail is required.
  • Excellent communications skills.
  • Establish and support a work environment of continuous improvement that supports BSC’s Quality policy, Quality System & the appropriate regulations for the area.
  • Ensure employees are trained to do their work and their training is documented.

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Management Requirements

  • Lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Job Scope and Leveling Guidelines

Scope


Accomplishes results through professional specialist employees or subordinate managers and supervisors who exercise significant latitude and independence in their assignments. Provides direction and monitors progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors company-wide indicators such as market share and profitability; monitors external environment in area of technical or professional responsibility. Subject to approval, modifies the organizational structure of centralized functions and units. Often responsible for managing a staff function of the company.

Supervision Provided

Works under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results. Work is reviewed by senior management in terms of meeting the organization’s objectives and schedules.

Supervision Provided

Provides direction and guidance to professional specialist employees or subordinate managers and supervisors. Provides guidance to subordinates within the latitude of established company policies. Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods, and staffing. Evaluates performance of and assists in career development planning for subordinates.

Job Complexity

Works on issues of large and diverse scope where analysis of situations or data requires expert knowledge of area of expertise and in-depth understanding of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. In some instances, this manager may be responsible for managing a staff function and may not have subordinate managers.

Policy Involvement

Establishes operating policies and procedures that affect immediate subordinate organizational units and may have company-wide effect. Interprets, executes, and recommends modifications to organizational policies. Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups

Operations Involvement/Direct Work Involvement

Functions as an advisor to subordinates supervisors or staff members to meet schedules or resolve technical or operational problems. Develops and administers budgets, schedules, and performance standards. Investigates and solves problems that impact work processes and personnel within or across units or departments.

Project Involvement

Responsible for all projects assigned to the organizational unit. Defines projects based on identified strategies and goals. Manages projects of moderate to large scope including schedules, costs and resources. May lead or participate in cross-functional teams.

Planning and Organization

Creates mid- to long-range plans to carry out objectives established by top management. Develops and calculates a budget for a department or group to meet organizational goals; forecasts future departmental needs including human and material resources and capital expenditures; recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.

Impact

Assignments are expressed in the form of objectives; makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Exerts influence in the development of overall strategy, objectives and long-range goals of the organization. Erroneous decisions or recommendations would normally result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and may jeopardize future business activity.

Influence and Leadership

Develops and communicates a vision for the organizational unit assigned. Builds consensus for operating goals that are in alignment with the division. Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives.

Liaison

Frequently interacts with subordinate supervisors, equivalent level managers, and/or customers, normally involving matters between functional areas, other company divisions or units or customers and the company. Conducts briefings and technical meetings for internal and external representatives concerning operational decisions, scheduling requirements, or contractual clarifications

Qualifications
  • Degree (HETAC Level 8) qualified, in a relevant field with a minimum of 8 years' work experience in a medical device environment
  • People management experience is desirable
  • Direct regulatory affairs experience with higher class devices desirable

For further information on this Regulatory Affairs manager role in Galway please contact Bimi Felix on 086 8395533 / recruit@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.

Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

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“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

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“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
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“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
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“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
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Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

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Clients we are proud to work with

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