Elekta Job - 33838318 | CareerArc
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Company: Elekta
Location: MI
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

  Want to join a team with a mission to improve and save lives?  

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

Summary

The main responsibility of the Senior Regulatory Affairs Specialist is to support the Oncology Informatics Medical Device Software organization in achieving regulatory goals and objectives, proactively ensuring the organization is achieving and maintaining the necessary global regulatory clearances needed. The selected experienced candidate will be responsible for developing regulatory strategies for submissions to global regulatory authorities to introduce new devices to market and maintain compliance of existing products. 

This position is primarily based in the St. Charles, MO office but we will also consider remote candidates

Responsibilities:

  • Prepare and coordinate documentation for regulatory submissions, product registrations, license renewals, and annual registrations in domestic and international markets (e.g. EU CE mark, FDA 510(k), Canadian licenses, NMPA registration, etc.).

  • Develop regulatory strategies for new devices and post-market modifications to ensure business goals are met. Clearly communicate strategies, associated potential risks and mitigations to organization stakeholders.

  • Represent Regulatory Affairs on product development projects to identify regulatory requirements and ensure they are incorporated into the development processes

  • Develop and maintain product technical files to ensure compliance to applicable regulations and standards including supporting UDI requirements

  • Proactively research and assess regulatory intelligence to product applicable Global regulations, statutes, guidance and standards for Oncology Informatics products ensuring appropriate implementation. Provide regular, accurate regulatory recommendations, updates, decisions, training, and feedback to organization stakeholders.

  • To facilitate standards compliance verification activities and standards compliance for the Oncology Informatics products

  • Provide post market support for products to ensure compliance with regulatory requirements. This may include reviewing product labeling, promotional/marketing materials and other documentation for changes requiring submission to regulatory authorities.

  • Provide regulatory support to the Global Commercial groups

  • Liaise with external regulatory authorities and internal functions within Elekta

  • Perform regulatory review of business documentation e.g. Field change Orders, Marketing material, application training etc.

  • Provide regulatory status reporting to management

  • Participate in audits as the Regulatory Subject Matter Expert

  • Write or maintain standard operational procedures, work instructions or policies.

  • Coordinate regulatory assignments with other Regulatory associates in assigned responsibilities

  • Create and prioritize projects as needed

  • Other duties as assigned or required

  • Occasional travel up to 15% may be required

We offer:

  • Excellent Medical, Dental, and Vision coverage

  • 401k, paid Vacation and Holiday

  • A wealth of additional benefits including Wellness Reimbursement, Tuition Reimbursement and Flexible Spending Account

  • Opportunity to work in the cutting edge in medical advancement

  • Close knit company culture

  • Upward mobility

Qualifications:

  • Bachelor's degree in Biology, Chemistry, Engineering, or Regulatory Affairs or related discipline and 5+ years of experience in Medical Device Regulatory Affairs with Class II and III devices or the equivalent combination of education and experience

  • Demonstrated advanced working knowledge of federal/international medical device regulations, guidance, and standards (e.g., EU MDD/MDR, FDA, CMDR, international) applicable to Class II and III medical devices. Medical Device Software experience desired.

  • Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional areas

  • Experience supporting new product development and product change control projects. Intermediate knowledge of design control, product lifecycle, product development, and product change control. 

  • Ability to interpret, adapt and explain regulatory framework and requirements

  • Excellent interpersonal and communication skills across all functions and geographies

  • Proactive and solutions orientated. Fosters collaboration among team members.

  • High level of computer proficiency with Microsoft Office, file management and regulatory applications and databases

  • Strong work ethic and attention to detail

  • RAPS Regulatory Affairs Certification (RAC) certification preferred 

EEO Statement

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic


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