Regulatory Affairs Senior Associate
ProClinical is happy to advertise an opportunity for a Senior Regulatory Affairs Specialist position with a leading medical devices company. Specialising in combining medical devices with biologic materials and cellular therapies, this company is seeking for a talented and hard-working individual to join their team based in Ireland.
The Senior Regulatory Affairs Specialist will assist in the running of the regulatory affairs by providing input into regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets, and providing regulatory affairs input for the functional areas.
- Assisting in the running of the company's regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
- Assisting in implementing regulatory requirements in accordance with OSI13485, MDD 93/42/EEC, and FDA 21CFR Part 820 as required, along with any other jurisdictions.
- Maintaining an excellent understanding of the products assigned to the team.
- Improving the function of the Regulatory Affairs Department.
- Understanding the progress of the RA team on assigned tasks and removes roadblocks.
- Providing supporting to the RA team members to complete assigned tasks.
- Mentoring and training new RA team members.
- Highlighting any updates to regulatory requirements to regulatory management.
- Planning and preparing regulatory submissions for specific target markets for new products, product changes, and re-registrations as needed; collaborating with their assigned regulatory specialists on same.
- Reviewing submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
- Developing global regulatory strategies for company medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
- Advising other functional units (engineering, marketing, operations, quality, etc) of the requirements in each target market and updating same on approval status in target markets.
- Ensuring the biocompatibility requirements of the product are adequately addressed.
- Ensuring the clinical requirements of the product are adequately addressed.
- Ensuring the outputs from the individual functional units (engineering, marketing, etc) meet the applicable regulatory requirements.
- Communicating project/submission status directly to RA Management and other stakeholders as required.
- Communicating directly with regional regulatory agencies/notification bodies to ensure product clearances are achieved in a timely manner.
- Serving as a liaison on regulatory issues between the company Manufacturer and the company International local office and/or company Distribution partner.
- Coordinating multiple projects at one time and providing regular reports to regulatory management and others, as required
- Maintaining a system for registration information (license numbers, expiration dates, etc) and obtaining re-registration approvals in advance of license expirations to ensure there is no disruption in product availability.
- Providing support to currently marketed products as necessary, including input on change requests, etc.
- Maintaining and organising appropriate regulatory records to demonstrate compliance with applicable regulations.
- Providing regulatory support to company functional units, such as the SSC, tenders, customer quality, and distribution.
- Ensuring that the company's Code of Conduct is considered in all business matters carried out on company behalf.
- Performing additional duties as assigned.
- Acting as a designee for the Regulatory Affairs Manager, and the Regulatory Affairs Specialist.
Skills and Requirements:
- A third level Qualification, preferably in a Science/Quality field.
- A thorough knowledge of requirements in CHTF countries, including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, and FDA 21CFR Part 820, as required.
- Approved External Auditor.
- Knowledge of requirements in other jurisdictions where required.
- Knowledge of medical device quality standards/practices, or similar regulated industry.
- Excellent communication, persuasion, and inter-personal skills.
- Proven problem-solving skills.
- Proficiency in Microsoft Office, along with general computer skills.
- Proven organisational skills.
- Willingness and availability to travel on company business.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Roberto Esposito on +44 203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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