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    Sr. Regulatory Affairs Specialist - San Diego, United States - Philips

    Philips
    Philips San Diego, United States

    2 weeks ago

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    Description
    Job TitleSr.

    Regulatory Affairs SpecialistJob DescriptionA core member of the cross-functional team, the Regulatory Affairs Specialist develops and executes regulatory strategy, supports design controls deliverables, and reviews promotional materials for medical device new product introductions, design changes, and regulation changes in alignment with company objectives.


    Your role:

    • Interprets regulatory requirements for medical devices; creates detailed regulatory plans for domestic and international distribution of medical devices; reviews and approves design controls deliverables and promotional materials from a regulatory perspective; prepares regulatory submissions for medical devices; and maintains regulatory clearance through the product lifecycle.
    • Interfaces with internal stakeholders such as marketing, engineering, research and development, manufacturing, quality, service, and clinical. Interfaces with external stakeholders such as auditors/inspectors, regulatory submission reviewers, notified bodies, and suppliers.
    • May expect up to 10% travel annually within the USA (primarily Florida) with some international travel possible.
    • Provides opportunities to develop regulatory skills pertaining to multi-parameter patient monitors, software, specialized clinical environments, radios, and batteries; continuing education in LEAN principles, regulatory affairs certification (RAC), and regulation certifications; and growth to senior, principal, and/or manager roles.

    You're the right fit if:

    • You've acquired at least 3 years of experience in the medical device industry with regulatory submission experience (FDA class II equivalent).
    • Your skills include strong written, oral, organization, problem solving, and interpersonal skills to effectively compose agency submissions, communicate with regulatory agencies and auditors, interface with various departments (engineering, supply chain, quality, etc.), and complete assignments with minimal supervision.
    • You have a bachelor's degree or equivalent preferably in regulatory affairs or science-related field or equivalent experience in the medical device industry.
    • You have a strong background in design controls and an excellent working knowledge of medical device regulations and standards (21 CFR, EU Medical Device Regulation, ISO 13485, etc.).
    • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
    Philips Transparency DetailsThe pay range for this position is $82,992 to $153,216, annually.

    The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

    In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.

    Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

    Details about our benefits can be found here.

    At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

    About PhilipsWe are a health technology company.

    We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.

    Do the work of your life to help improve the lives of others.
    • Learn more about our business.
    • Discover our rich and exciting history.
    • Learn more about our purpose.
    • Read more about our employee benefits.

    If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.

    You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
    Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
    Company relocation benefits will not be provided for this position.

    For this position, you must reside in or within commuting distance to San Diego, CA, Orlando FL, Nashville TN, Cambridge MA, Colorado Springs, CO, Maple Grove MN.

    USAThis requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

    Interested candidates are encouraged to apply as soon as possible to ensure consideration.
    Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.#J-18808-Ljbffr
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