Medical Device Regulatory Affairs Strategist

divh2Medical Device Regulatory Affairs Strategist/h2pAt a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracles success and competitiveness in the healthcare and life sciences sector./ppAs a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical device). You will help prepare the required documentation to register products in global markets where the products are sold. You will establish strong partnerships with the business to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch to post-market activities of software products in scope. You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting, responses to regulatory inquiries, and post-market compliance (e.g. advertising/promotion, etc.), as applicable. You will work primarily with the Oracle Health Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work./ppOracles Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracles technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracles Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery./ppWhat Youll Do:/pulliWork closely with Oracles product engineering teams to assess product functionality and develop regulatory strategy./liliCollaborate cross-functionally with other teams to create and manage pre-market submissions (including 510(k), CE Marking under EU MDR, Technical Files, applications to Health Canada, and other global submissions) across global market ensuring compliance with regulatory authorities./liliMaintain documentation and post market surveillance report on an ongoing basis to maintain market authorization./liliSupport internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies./liliServe as a subject matter expert for internal clients with interpretation of applicable standards and regulations, and use of the quality management system./liliManage and compliance related projects for Health-related products./liliReview and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance./liliMaintain compliance with changing regulatory requirements across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs./li/ulpPreferred Qualifications:/pulliBA/BS or advanced degree preferred./liliExperience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent./liliExperience authoring submissions (510k, EU Tech Files, etc.) required./liliExperience with sustaining and new product development is ideal./liliExperience interacting with notified bodies and/or regulators preferred./liliAbility to perform in a fast-paced and continually evolving business environment./liliRAC, CQE, CPPS, CQA desired./liliExperience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations./liliUnderstands continual improvement and risk management./liliExcellent written and verbal communication skills./liliAbility to adjust and adapt to changing priorities in a dynamic environment./li/ulpDisclaimer:/ppCertain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates./ppRange and benefit information provided in this posting are specific to the stated locations only./ppCA: Hiring Range in CAD from: $66,800 to $145,900 per annum. US: Hiring Range in USD from: $87,000 to $178,100 per annum. May be eligible for bonus and equity./ppOracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracles differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following:/pulliMedical, dental, and vision insurance, including expert medical opinion/liliShort term disability and long term disability/liliLife insurance and ADD/liliSupplemental life insurance (Employee/Spouse/Child)/liliHealth care and dependent care Flexible Spending Accounts/liliPre-tax commuter and parking benefits/lili401(k) Savings and Investment Plan with company match/liliPaid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits./lili11 paid holidays/liliPaid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours./liliPaid parental leave/liliAdoption assistance/liliEmployee Stock Purchase Plan/liliFinancial planning and group legal/liliVoluntary benefits including auto, homeowner and pet insurance/li/ulpThe role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC4 This role will be working on a regular basis with colleagues around the world. To support this collaboration, knowledge of English is required for this role. Proficiency in French is required for candidates residing in Quebec, otherwise it is considered an asset./ppAs a world leader in cloud solutions, Oracle uses tomorrows technology to tackle todays challenges. Weve partnered with industry-leaders in almost every sectorand continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. Thats why were committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. Were committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law./p/div