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Vacancy Details

Quality

Senior Regulatory Affairs Specialist - Roscommon

Contract Type: Permanent
Sector:
Location: Roscommon
Date: 22/03/2019
Job Reference: 101837
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Senior Regulatory Affairs Specialist

Our client, a medical device company in Roscommon is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.


Responsible for providing Regulatory support through the Design and Development and change control process. Plan, prepare and submit regulatory submissions. Provide support to RA with all international country submissions. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations

Employees are expected to support the quality concepts inherent in the business philosophies, including a variety of job-related tasks which may not be specific to this position profile.

Responsibilities
Compliance
  • Identifying new regulations and standards that impact regulatory compliance
  • Complete technical review, of manufacturing location process validation documentation in line with MDR requirements and update where required.
  • Provide technical guidance in relation to regulatory requirements associated with the MDR
  • Liaise with all departments to ensure continued corporate compliance
  • Support Management review and Management of external 3rd party audits.

Design support
  • Provide Regulatory support to new product introduction and product transfers teams.
  • Plan, prepare and submit regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
  • Ensures the biocompatibility requirements of the product are adequately addressed.
  • Ensures the clinical requirements of the product are adequately addressed.
  • Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
  • Ensure the outputs from the individual functional units (engineering, labelling, packaging, marketing etc.) meet the applicable regulatory requirements.
  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
  • Provides support to currently marketed products as necessary including input on change requests, etc.
  • Maintains and organises appropriate Technical files and regulatory records to demonstrate compliance with applicable regulations.

Regulatory Affairs Support
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
  • Provide support to RA with all international country submissions
  • Provides support to currently marketed products as necessary including review and approve all related change orders and perform the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements
  • Negotiates with regulatory authorities throughout the product lifecycle.
  • Provide support to solve and reply to any regulatory query.
  • Help to manage and maintain all RA documentation including Technical Master File
  • Support all Product design and process changes requiring regulatory support

Operational Support
  • Provide ongoing regulatory support to help the team meet its business objectives.
  • Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs.

Education:
  • School education level
  • University / technical college education level

Experience:
• Previous regulatory experience in a similar work environment is essential.

Competencies Required:
  • Experience in working Medical Device Manufacturing Facility
  • Strong computer skills - Change control management; design, process and system.
  • Familiarity with ISO quality systems (MDD 93/42/EEC/MDR - ISO13485 – 21 CFR 820)
  • QMS Internal auditing skills
  • Good customer relation skills
  • Ability to present an independent opinion
  • Good communication and interpersonal skills -communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
  • Quality of work / Attention to detail; maintains high standards despite pressing deadlines
  • Problem Solving (using recognised tools) and decision making (makes sound factual decisions)
  • Risk Management including FMEA generation


For further information on this Senior Regulatory Affairs Specialist role in Roscommon please contact Bimi on 086 8395533 / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – 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,
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“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”. 

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"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 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”.

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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”. 


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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,
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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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“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”.

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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”. 


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Clients we are proud to work with

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