Regulatory Affairs Specialist II - Medical Devices Submissions
Highridge Medical LLC
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 in Regulatory Affairs and a relevant bachelor's degree. The position requires strong communication skills, attention to detail, and the ability to manage multiple priorities. Travel of up to 15% is expected for this position. #J-18808-Ljbffr
- ...Regulatory Affairs Specialist II Principal Duties and Responsibilities: ~ Assist with... ...process, including the regulatory submissions process. May author and publish electronic... ...of regulations pertinent to medical devices, biologics, drugs and combination...Medical deviceWork at office
- A dynamic medical device organization located in Westminster, Colorado, is looking for an entry-level Regulatory Associate to join their team in July 2026. This in-office position... ...with US and international regulatory submissions, reviewing documentation for readability...Medical deviceWork at office
- .... Must Have Experience in medical device regulatory Proven ability to develop... ...authoring and leading 510(k) submissions and EU Change... ...experience with class I and II electrical and software-based... ...The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for...Medical device
- ...Overview This Associate Regulatory Affairs Specialist (RAS) is based in Lafayette... ...document packages for regulatory submissions, internal audits, and... ...to Have Experience in medical device regulatory affairs. Strong... ...experience with Class I and II electrical and software‑based...Medical deviceLocal areaRemote work
$85k - $95k
...LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations and regulatory submissions for active implantable medical devices. The role entails preparing evaluation plans, managing submissions, and collaborating across teams to ensure compliance...Medical deviceRemote workFlexible hours- ...Senior Regulatory Affairs Specialist Job Description This person will be joining a small, but... ...those strategies to completion through submission in the US and internationally. You... ...of experience in orthopedic or medical device industry. ~(Required) A minimum of...Medical device
$74.4k - $111.6k
## Associate Regulatory Affairs SpecialistApplyremote type: Onsitelocations... ...Regulatory Affairs Specialist (RAS) is responsible... ...through regulatory submission and commercialization... ...*** Experience in medical device regulatory* Strong... ...with class I and II electrical and software...Medical deviceH1bWork at officeLocal areaRemote workFlexible hours- Highridge Medical LLC is looking for a Quality Engineer to join their team in Westminster, Colorado. The ideal candidate will gather and... ...and 5+ years of relevant experience are required, with medical device experience being strongly preferred. Certification as a Quality...Medical device
- Regulatory Associate page is loaded## Regulatory Associatelocations... ...operational facets of a regulatory affairs career. As an RA team member... ...to facilitate international submissions. You will have the... ..., and immerse yourself in a medical device organization committed to its...Medical deviceWork at officeLocal area
- ...As an Associate Medical Science Liaison (... ...use of Aerogen’s devices by engaging with... ...solutions in line with regulatory, cybersecurity,... ..., Regulatory Affairs, Quality Engineering... ...and execute submission delivery plans for... ...Regulatory Affairs Specialist II (Strategic Regulatory...Medical deviceContract workWork at officeLocal areaImmediate start
- A medical device company in Wheat Ridge, Colorado, is seeking an experienced FEA Engineer to conduct simulations of structural heart and endovascular implants. The ideal candidate will possess a Bachelor's or Master's degree in Engineering, with over 5 years of experience...Medical device
$75k - $95k
Boston Scientific is looking for a Field Clinical Representative II in Denver, Colorado, to provide expert clinical support for... ...experience in a clinical or sales role, with a preference for medical device experience. This full-time position offers an annual salary range...Medical deviceFull time- ...Medtronic plc is hiring an Associate Regulatory Affairs Specialist in Lafayette, Colorado. This role involves supporting regulatory strategy... ...teams to ensure compliance and drive product innovation. Medical device regulatory experience is preferred. Join us in making a...Medical device
- ...Field Clinical Representative II – Spinal Cord Stimulator At Boston Scientific,... ...in full compliance with all applicable regulatory guidelines. Failure to properly perform... ...role. Preferred Qualifications: Medical device sales and/or clinical education experience...Medical deviceWork experience placementWork at officeNight shift
$30 - $33 per hour
...Quality Control & Quality Affairs (QC/QA) Associate II Join Our Team as a Quality Control & Quality... ...Technical writing experience (SOP, Regulatory submissions, technical reports) Work... ...benefits package that includes: ~ Medical, Dental, and Vision Insurance Plans...Hourly payFull timeTemporary workMonday to FridayFlexible hours- Working at Highridge Medical is not just work.... ..., Marketing, Regulatory, Quality, Operations... ...Coordinates with Regulatory Affairs to ensure project... ...support global submissions and compliance... ...of medical device product development... ...environment (Class II/III preferred)** *...Medical deviceWork at office
- ...suppliers, and experts outside Highridge Medical to implement Highridge Medical quality... ...department and the company (suppliers, regulatory agencies, etc.). Facilitate team efforts... ...in a Quality Engineering role; medical device experience strongly preferred. Combination...Medical deviceWork at office
$75k - $95k
...Field Clinical Representative II – Spinal Cord Stimulator... ...and physicians.As a Clinical Specialist 2, you’ll partner with healthcare... ...with all applicable regulatory guidelines. Failure to properly... ...role.Preferred Qualifications:Medical device sales and/or clinical...Medical deviceFull timeWork experience placementWork at officeNight shift$60 - $83 per hour
...Job Description Job Title : Flight Software Engineer II Position Description : Protingent Staffing has an exciting contract... ...- from Software and Aerospace to AI, Clean Tech, Medical Devices, and Connected Technologies . We're passionate about making a...Medical deviceContract workWork experience placement- ...implants, as well as MRI heating CM&S for a wide range of medical devices. This role requires a driven, collaborative, proactive... ...Experience in writing CM&S reports (for medical device regulatory submissions, preferred) Experience with structural heart / endovascular...Medical device
$70k - $109k
...applying to join CONMED as a Mechanical Engineer II. This position is for a critical member... ..., reliable, disposable and/or capital medical products for use in surgical procedures,... ...manufacturing, ensuring compliance with medical device standards and regulations. Complete...Medical deviceTemporary workWork experience placementImmediate start- ...this role, you will be responsible for driving sales revenue targets, managing customer engagements, and providing support for medical device products. You will play a key role in building relationships with clinicians and distributors, while collaborating with the marketing...Medical device
- Arrow Electronics is seeking a Trade Compliance Specialist II in Denver, Colorado. This role ensures compliance with U.S. export laws and facilitates clearances for shipments. Successful candidates will have proven skills in international logistics and U.S. export regulations...
- ...Trade Compliance Specialist II Arrow Electronics is a global provider of products, services... ..., information systems, transportation, medical, industrial, and consumer electronics.... ...instructions. Provide analysis & regulatory guidance on preferential warehousing and...Hourly payPermanent employmentFull timeTemporary workWork experience placementWork at officeLocal areaWorldwide2 days per week
$83k - $100k
...concept to launch. Ideal candidates will have a B.S. in Mechanical Engineering or related fields and 3-7 years of experience in the medical device industry, specifically orthopaedic devices. Proficiency in CAD design, particularly using SolidWorks, is essential. This full-...Medical deviceFull time$25.48 - $60.63 per hour
...Come be a part of the Oracle Health CareAware Device Integration team and aid our clients integrate various medical devices for seamless exchange of data from device... ...travel. As an Integrated Technologies Consultant II, you will be responsible for providing consulting...Medical deviceHourly payTemporary workWork experience placementLocal areaRemote workMonday to ThursdayFlexible hours$80k - $115k
...Systems is looking for our next Quality Assurance/Compliance Specialist II. As a Quality Assurance/Compliance Specialist II on the NISSC... ...will help ensure compliance with AS9100D, FAR, contract, and regulatory requirements, while providing quality metrics, reports, and...Contract work$61.3k - $122.7k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...developments in field(s) of expertise, regulatory requirements, and a good working knowledge... ...a minimum of 6 months in Clinical Specialist position. Minimum of 2 years clinical...Medical device- ...support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint... ...regulatory writing, regulatory affairs, laboratory sciences, quality assurance...Medical deviceFull timeRemote work
$19.5 - $21 per hour
Assembly Technician I Job Summary: The Assembly Technician I will work under general supervision to assemble and package product components, handle materials, and operate manufacturing equipment while following established policies, practices, and procedures. Responsibilities...Medical deviceHourly payShift work
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