Regulatory Strategy Lead Medical Devices & 510(k) Expert
IntePros
A medical device company is seeking a Principal Regulatory Affairs Specialist to oversee regulatory activities for the INVOS™ Cerebral/Somatic Oximetry product line. The role requires at least 7 years of regulatory experience within medical devices. The successful candidate will work collaboratively with various teams to ensure compliance and will direct regulatory submissions including 510(k)s. Ideal applicants must demonstrate strong knowledge of EU MDR and FDA processes, and be capable of mentoring junior staff. #J-18808-Ljbffr
- ...A leading medical device company in Colorado is seeking a Principal Regulatory Affairs Specialist. The role involves coordinating regulatory submissions, including 510(k) and collaborating with cross-functional teams to ensure compliance. Candidates should have a University...RegulatoryMedical device
- ...Medtronic is seeking a Principal Regulatory Affairs Specialist to provide regulatory... ...in Lafayette, CO. You will lead global regulatory strategies and serve as a strategic partner across... ...degree and significant experience in medical device regulatory affairs. The position...RegulatoryMedical device
$178.4k - $267.6k
...equity for all. You'll lead with purpose, breaking... ...Unit's most complex regulatory and operational programs... ...global market access strategies, and operational readiness... ...working in the medical device, life sciences, or other... ...Incentive plans, 401(k) plan plus employer contribution...RegulatoryMedical deviceH1bWork at officeLocal areaFlexible hours$160.8k - $241.2k
...equity for all. You'll lead with purpose,... ...lead the long-term strategy for the PillCam... ...technologies, and regulatory trends to inform product... ...Partner with Medical Affairs to shape clinical... ...or medical devices Experience influencing... ...plans, 401(k) plan plus employer...RegulatoryMedical deviceWork at officeLocal areaFlexible hours- ...The Principal Regulatory Affairs Specialist (Pr. RAS)... ...Strong experience with 510(k)s and presubs, and experience... ...experience with medical devices that have integrated software... ...and inspections. Leads and compiles all... ...regulatory requirements and strategy are integrated into...RegulatoryMedical deviceRemote work
- ...organization. Must Have Experience in medical device regulatory Proven ability to develop and execute robust regulatory strategies Proven experience authoring and leading 510(k) submissions and EU Change... ...function as a subject matter expert within the organization and as...RegulatoryMedical device
- ...Overview This Associate Regulatory Affairs Specialist (RAS) is based... ...when necessary. Recommend strategies to bring products to market... ...Nice to Have Experience in medical device regulatory affairs. Strong... ...experience authoring and leading 510(k) submissions and EU Change...RegulatoryMedical deviceLocal areaRemote work
$120k - $180k
...for all. You’ll lead with purpose, breaking... .... The Principal Regulatory Affairs... ...global regulatory strategies across early development... ...subject matter expert and individually... ...Extensive experience in medical device regulatory... ...submissions (e.g., 510(k), PMA) and EU Technical...RegulatoryMedical deviceH1bWork at officeLocal areaFlexible hours$138.4k - $207.6k
...access and equity for all. You’ll lead with purpose, breaking down... ...while adhering to safety and regulatory standards. Manages project... ...and commercialization in the medical device industry ~ Strong... ...employees: Incentive plans, 401(k) plan plus employer contribution...RegulatoryMedical deviceH1bWork at officeLocal areaFlexible hours- ...Responsibilities: The Associate Regulatory Affairs Manager will support... ...of regulatory documents for medical device and IVD products. This... ...submission process for 510(k), Technical Files, and other... ...appropriate submission strategies. Participate in internal...RegulatoryMedical deviceWork at office
$110k - $135k
...Integrated DNA Technologies is seeking a Regulatory Affairs professional to lead the creation of regulatory documents and ensure compliance with FDA and EU regulations. Located in Boulder, CO, this fully remote role requires a Bachelor's degree in a technical field and...RegulatoryRemote work- ...Regulatory Affairs Specialist This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product... ...necessity for submitting a 510(k) application for proposed device...RegulatoryMedical deviceWork at office
$169.98k - $254.98k
...Architects provide expert guidance to an... ...engagements. Develop strategies to improve and optimize... ...with external regulatory and security... ...lessons learned and leading practices through... ...disability benefits, 401(k) plan and company... ...or related medical conditions (including...RegulatoryLocal areaFlexible hours$86.4k - $129.6k
...Senior Medical Education Curriculum Specialist... ...curriculum strategy, learning... ...portfolios. Lead the design and... ...Affairs, clinical experts, and physician... ...Medtronic policies, regulatory requirements,... ..., medical device, pharmaceutical... ...Incentive plans, 401(k) plan plus...RegulatoryMedical deviceH1bWork at officeLocal areaFlexible hours- ...Specialist Client: Medical Device Manufacturing Industry... ...and advancing website content strategy for digital experiences.... ...marketing, UX, SEO, tech, clinical, regulatory) to deliver cohesive and high... .... Responsibilities Lead large-scale website content...RegulatoryMedical deviceFull timeShift workDay shift
$161k - $200.6k
...AES Corporation is seeking a Senior Manager, Growth Strategy to lead cross-functional growth planning and project origination. This... ...ranges from $161,000 to $200,600 annually, with additional benefits including medical coverage and 401(k) eligibility. #J-18808-Ljbffr...$150.4k - $225.6k
...equity for all. You’ll lead with purpose, breaking... ...applications for medical devices (primarily desktop applications... ...(quality, regulatory, and marketing) • Communicate... ...policies and strategies. Decisions impact program... ...Incentive plans, 401(k) plan plus employer contribution...RegulatoryMedical deviceH1bWork at officeLocal areaFlexible hours- ...Cleanroom Technicians to assemble life-saving medical devices in a clean, high-tech environment. The role requires attention to detail, regulatory compliance, and experience in medical... ..., including medical insurance and a 401(k) plan. Join a supportive team working towards...RegulatoryMedical device
- ...technical management of medical device design and development... ...Our vision is to be a leading medical company in the... ..., and risk management strategies.Utilize appropriate... ...ensure compliance with regulatory requirements and industry... ...Vision Insurance401(k) with limited company...RegulatoryMedical devicePermanent employmentTemporary work
$161k - $200.6k
...Fortune 500 company that's leading the charge in the... ...Senior Manager, Growth Strategy Overview Senior Manager... ...tactics Partner with Policy, Regulatory and Commercial teams to... ...childbirth or related medical condition, military or... ..., life insurance, 401(k) eligibility and paid...RegulatoryFor contractorsWork experience placementWorldwide$135.3k - $186.04k
...ensuring compliance with regulatory requirements, negotiating... ...across the organization. Leading complex negotiations and... ...management on subcontracting strategy, risk management, and... ...benefit package, including medical, dental, and vision plans, 401(k) with 150% match up to 6%...RegulatoryContract workWork experience placement$115.2k - $172.8k
...access and equity for all. You’ll lead with purpose, breaking down... ..., role mapping, training strategy, content coordination, completion... ...guidance in interpreting policies, regulatory and/or governmental... ...employees: Incentive plans, 401(k) plan plus employer contribution...RegulatoryFull timeWork experience placementH1bWork at officeLocal areaFlexible hours$152k - $200k
...champion enterprise analytics strategy and serve as a catalyst... ...: Establish and lead a data stewardship... ...Ensure compliance with regulatory requirements (e.g., data... ...Healthcare benefits include medical, dental, vision, and... ...Retirement Savings Plan, a 401(k) savings plan with...RegulatoryContract workRemote workVisa sponsorshipWork visaRelocation package- ...Medtronic is seeking an Associate Regulatory Affairs Specialist in Lafayette, CO, focusing on regulatory activities for their medical device product portfolios. This role involves working with R&D, Quality, and Marketing teams to ensure compliance and facilitate product...RegulatoryMedical device
$131k - $174k
...architecture standards. Lead, coach, and develop... ...and services aligned to strategy and standards. Ensure compliance with regulatory, security, and internal... ...Healthcare benefits include medical, dental, vision, and... ...Retirement Savings Plan, a 401(k) savings plan with...RegulatoryPermanent employmentContract workFor contractorsRemote workVisa sponsorshipWork visaRelocation packageWeekend work- ...Highridge Medical LLC in Westminster, Colorado, is seeking a Regulatory Affairs Specialist II. This role involves developing regulatory strategies, assisting with submissions, and ensuring compliance with regulations. Candidates should have at least 3 years of experience...RegulatoryMedical device
$90k - $130k
...and HCPs by delivering expert product knowledge,... ...business development growth strategies, and practice... ...practices comply with regulatory, ethical, and organizational... ...experience in dermatological, medical devices, specialty... ...health insurance, 401(k) plan with employer match...RegulatoryMedical deviceContract workWork at officeShift workWeekend workAfternoon shift$75k - $85k
...more personalized treatment strategies for patients with cancer. We... ...reflect current practices and regulatory requirements, driving... ...clinical laboratory, diagnostics, medical device, or pharmaceutical. Solid... ...holidays Parental leave 401(k) with company match You will...RegulatoryMedical deviceWork at officeFlexible hours$197k - $285k
...Cerapedics has two drug-device products approved by... ...to our mission through leading and strengthening our... ...safety, effectiveness, and regulatory compliance of our... ...quality and compliance strategies, directing the... ...standards for drug and/or medical devices. Oversees...RegulatoryMedical deviceFull timeWork experience placementWork at officeWorldwide- ...integrate medium voltage and safety-critical systems for medical devices 2. Medical Device Regulatory Compliance & Safety Standards (IEC 60601) Hands-on... ...Engineer, you will serve as a technical leader and expert in designing, developing, and integrating complex...RegulatoryMedical deviceContract workWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Strategy Lead Medical Devices & 510(k) Expert. Be the first to apply!


