Talentify helps candidates around the world to discover and stay focused on the jobs they want until they can complete a full application in the hiring company career page/ATS.
Description
- Act as the regulatory affairs representative on new product development for assigned product portfolio
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission; develop regulatory strategy for US, Canada and international market(s)
- Write, analyze, and edit technical documents (e.g., 510(k), Letter-To-File, License Amendments) to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents
- Maintain regulatory files, assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports
- Support and or lead in preparing response to regulatory authorities’ questions within assigned timelines
- Attend product development team meetings for each project
- Review and or approve Engineering Change Orders (ECOs)
- Collaborate with customer regulatory employees to route applicable Essential Requirements Checklists to product development team members, obtain feedback, and produce signed memo, as required
- Produce project status reports to R&D Project Manager
Additional Skills & Qualifications
- At a minimum, completion of a Bachelor's (e.g. Life/Physical Science, Engineering, Business, etc.) is required. Additional training in regulatory affairs, quality assurance, project management, risk management, etc. is strongly preferred. Advance degree is also strongly preferred
- A minimum of 4+ year of related job experience is required for this position
- Experience within the medical device and biotechnology industry and expert knowledge of FDA (required) and Canada (highly preferred) regulatory requirements is a must
- Proven experience writing 510(k) submissions and Letters to File
- Strong computer skills in appropriate software applications and related systems required
- Demonstrated knowledge and experience in the following areas: new product development, regulatory submission, compliance, complaint handling, medical device risk management processes, regulatory policy are preferred
- Project management experience is preferred
- Experience mentoring/coaching and providing training to others is preferred
- Must have strong written and oral communication skills
- Must have a flexible mindset with the ability to work in a fast-changing environment
- Ability to travel to support client and company meetings is a must (up to 10%); for domestic, trans-border and international, as required
Experience Level
Intermediate Level
À Propos D'Actalent
Actalent relie la passion à la mission. Nos solutions de candidats talentueux et la performance de nos services produisent la valeur et les résultats, tout en apportant la compétence qui permet à nos clients de réaliser plus. Nos experts situés dans le monde entier inspirent au quotidien. Nous soutenons les initiatives essentielles en ingénierie et en sciences, par les expériences qui favorisent un développement continu. La différence, c’est nos gens. Actalent est une société d’exploitation d’Allegis Group, leader mondial des solutions de candidats talentueux.
L’entreprise souscrit au principe d’égalité d’accès à l’emploi et prendra en compte toutes les candidatures sans distinction de race, sexe, âge, couleur, religion, nationalité, statut de vétéran, handicap, orientation sexuelle, identité sexuelle, information génétique ou toute autre distinction protégée par la loi.
About Actalent
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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