Regulatory Affairs Specialist

Tired of working at a good job

At Elevaris our goal is not to be good its to be extraordinary.

Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.

Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the worlds leading manufacturers of madetospec procedural needles. Beyond needles we are also a Contract Development and Manufacturing Organization (CDMO) to industryleading multinational healthcare companies global original equipment manufacturers (OEMs) and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products surgical instruments and medical supplies.

POSITION SUMMARY

We are looking for a highly motivated and resultsdriven Regulatory Affairs (RA) Specialist to join our Regulatory Affairs team. The RA Specialist is responsible for supporting the Regulatory Affairs Manager in global registrations and ensuring that medical devices and pharmaceuticals meet all regulatory requirements for countries where the devices are marketed. This role is also responsible for preparing and submitting global regulatory documents and assisting the Regulatory Affairs Manager in providing guidance and support to crossfunctional teams on regulatory matters related to global markets.

ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES:

• Daytoday operations supporting global submission activity US pharmaceutical state licensing document legalization and processing working with crossfunctional teams to obtain registration documents.
• Provide clinical evaluation documentation (CER/CEP SSCP and PMCF) support to comply with EU MDR requirements.
• Claims matrix implementation for medical device(s) and pharmaceuticals work with crossfunctional experts
• Establish best practices for claims matrix and legacy marketing material review and obsolescence
• Improvement project for Post Market create a post market requirements checklist for regulatory evaluation process for project team deliverables to support RA post market submission activity; start with USA and EU
• Maintenance of technical files and DHF files
• Appropriately legalize notarize endorse documentation for global regulations.
• EUDAMED and GUDID support

MINIMUM REQUIREMENTS:

• Bachelors degree in a scientific or technical discipline
• 01 years of experience in regulatory affairs with a focus on global medical device registrations
• Knowledge of global regulations and standards for medical devices and pharmaceutical

PREFERRED SKILLSET:

• Biocompatibility and Sterilization knowledge
• Excellent organizational verbal written communication and problemsolving skills
• Ability to work accurately in a fastpaced everchanging environment

BENEFITS:

We offer a robust array of employee benefits designed with your total wellbeing as the focus:

• Paid vacation sick time and 13 paid holidays/year

• Schedule flexibility and Work At Home Wednesdays

• Health Dental and Vision plans (including Domestic Partner coverage)

• A companyfunded HRA which pays the bulk of your medical plan deductible

• FSA & Dependent Care FSA

• Company paid Life Short & Long Term Disability Insurance

• Employee Assistance Program

• Company paid membership to Care for child elderly or pet care assistance support

• Voluntary Life Accident Critical Illness and Hospital Indemnity insurance options

• 4o1k Retirement Plan with company match

• A Healthy Rewards program that offers discounts on a wide variety of health and wellbeing options

• Company paid Emergency Travel Assistance

• Myriad employee events recognitions and celebrations to ensure Elevaris employees know they are valued!

PHYSICAL DEMANDS & ADA STATEMENT:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers coworkers and external partners. Contact your manager or HR to understand the Work Conditions and Physical requirements that may be specific to your role.

An Equal Opportunity Employer: Spectra believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race color creed religion genetic information sex sexual orientation national origin age status with regard to public assistance marital or veteran status disability or any other characteristic protected by local state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employeremployee relationship including recruitment hiring training promotion transfer discipline layoff recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.