Regulatory Affairs Manager, Contract
- Employer
- Thornshaw Recruitment
- Location
- Limerick (County), Munster (IE)
- Salary
- Negotiable
- Start date
- 27 Sep 2019
- Closing date
- 27 Oct 2019
View more
- Discipline
- Regulatory Affairs, Compliance, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
Job Details
On behalf of my client, a multinational medical device company, I am recruiting for a Regulatory Affairs Manager. This is a maternity cover role.
In this role you will be responsible for the following:
• Responsible for supervising the day to day workload and operational issues of the regulatory affairs team.
• Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required and other jurisdictions as required.
• Mentors and trains new RA team members.
• Highlights any updates to regulatory requirements to Senior Management.
• 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.
• Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
• Develops global regulatory strategies for Company medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
• Advise other Company functional units (engineering, marketing, operations, quality etc.) of the requirements in each target market and updates same on approval status in target markets.
• Ensures the biocompatibility requirements of the product are adequately addressed.
• Ensures the clinical requirements of the product are adequately addressed.
• Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
Applications are invited from candidates with the following background and experience:
• Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
• Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
• Knowledge of medical device quality standards/practises or similar regulated industry.
• Good communication and inter-personal skills.
• Proven problem-solving skills.
• Good computer skills including knowledge of Microsoft® Office.
• Proven organisational skills.
• High self-motivation.
• Approved External Auditor.
• Willingness and availability to travel on company business.
For more information and to apply for this role please forward your CV in strict confidence to dbolger@thornshaw.com or call Deirdre on +353 1 2784671
Thornshaw Scientific, a division of the CPL group. www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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