Our client, a medical device company in Clare is currently looking to recruit a Regulatory Affairs Specialist for their site.
Responsible for supporting all facets of regulatory support to market products. This includes developing regulatory submissions, managing departmental projects, requesting and reviewing site specific labelling, and providing guidance.
- Management of the RA function for all manufacturing transfers, manufacturing process changes, introduction of new critical vendors and new product introductions. This includes creating regulatory strategies and managing the execution of these to ensure minimal interruption in commercialization.
- Management of the submission of registration documentation to relevant regulatory agency or local representative:
- Prepares/Reviews Change Notifications to the EU design dossier for EU Class III products according to EU MDD 93/42/EEC, EU MDR 2017/745 and applicable NBOG guidance documents. This includes hosting on-site reviews by the Notified Bodies and being the main contact for reviews.
- Updates/Maintains of EU Technical Files for EU Class IIb as part of the CE Marking process (according to EU MDD 93/42/EEC and EU MDR 2017/745).
- Prepares/Reviews product registration for OUS countries to support the Demand Plan.
- Prepares/Reviews PMA supplements to FDA (Real Time Requests, 30 Day Notices, and Manufacturing Site Change Supplements) for changes to US Class III products/process
- Preparation of the site portion of the Annual Report for US Class III products to FDA.
- Regulatory approval of labelling for product transfers or new product introduction in accordance with relevant labelling requirement.
- Responds to requests from relevant regulatory agency or local representative relating to previously submitted documentation for marketing approval.
- Keeps all areas informed of regulatory requirements and emerging issues which may affect the registration approval of products
- Manages and approves any label requests for creation or update of OML specific labels associated with changes, new product introduction or new manufacturing transfer activities
- Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization
- Miscellaneous responsibilities as assigned
Expected Areas of Competence (i.e. KSAs)
- Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers,
- Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail
- Advanced knowledge of overall medical device business environment, with knowledge of orthopedic industry and products being advantages
- Demonstrated strong knowledge of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, as applicable
- Ability to function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization
- Ability to identify and assess business risks to develop Regulatory strategy
- Ability to handle increasing levels of responsibility
- Strong computer skills
- Advanced knowledge of FDA and EU regulations (including labelling regulations) and regulations outside of the US/EU as applicable
Education/ Experience Requirements
- Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
- 5 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU
- Regulatory Affairs Certification (US or EU) preferred
- A combination of education, experience, leadership, strategy and RA influence may be considered
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