Regulatory Affairs / Sr Regulatory Affairs Specialist – Spine

  Regulatory Affairs

Job title: Regulatory Affairs / Sr Regulatory Affairs Specialist – Spine

Company: Stryker

Job description: Are you interested in working for a global company where you can work across functions and on awide-varietyof projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunit

Are you interested in working for a global company where you can work across functions and on awide-varietyof projects As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World’s Best Workplaces, apply now! Need another reason to apply Here are 10 reasons to join our Regulatory Affairs team: Who we want: Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. What you will do: Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.) Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines What you need: Relevant work experience of 3 – 5 years Educational Qualification in Bachelor of Engineering, Science or related degree or Masters in a relevant field RAC(s) certification is good to have Strong competencies in Technical and management skills engaged in regulatory strategy and operations Demonstrate knowledge and skills in areas such as regulatory pathways risk-benefit analysis communication and collaboration internally and externally submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance and distribution Looking for candidates with previous experience in writing letters to file, CE Mark, Japan PMDA, China NMPA and 510(k) experience preferred. Know someone at Stryker Be sure to have them submit you as a referralprior to applyingfor this position. Learn more about ouremployee referral programat About Stryker Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting

Expected salary:

Location: Bangalore, Karnataka

Job date: Sat, 11 Jun 2022 22:00:48 GMT

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