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Regulatory Scientist 2
1 week ago
Overview The 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 Scientist Responsibilities 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.
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