Job title:
Regulatory Scientist 2
Company:
Cook Medical
Job description
OverviewThe Regulatory Scientist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Scientist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.Reporting to: Principal Regulatory ScientistResponsibilities
- Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
- Ensures a thorough understanding of the products they are assigned.
- Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
- Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable).
- Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
- Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
- Plans and prepares regulatory submissions for specific target markets for new products and product changes as required.
- Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
- Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
- Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
- Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
- Provides support to currently marketed products as necessary including input on change requests, etc.
- Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
- Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
- Performs additional duties as assigned.
- Can act as a designee for the Regulatory Affairs Specialist or Regulatory Affairs Senior Scientist if required.
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Qualifications
- Third level Qualification in any of the following areas: Science, Engineering, or Clinical, such as Pharmacy or Nursing, desired.
- 2 years’ experience in a regulated industry in a similar role would be advantageous.
- Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation would be advantageous. Particularly in relation to the EU (MDD 93/42/EEC, EU MDR 2017/745). (Clinical & Post Market Surveillance Role)
- Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
- Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form.
- Participate in a team-based environment.
- Proven problem-solving skills.
- Good technical writing skills; advantageous to have medical writing experience.
- Knowledge / use of search databases for published literature (Embase, PubMed etc.)
- Good computer skills including knowledge of Microsoft ® Office.
- Proven organisational skills.
- High level of self-motivation.
- Willingness and availability to travel on company business as required.
Expected salary
Location
Limerick
Job date
Fri, 21 Mar 2025 00:01:59 GMT
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