Regulatory Affairs Specialist (REMOTE)
Posting ID: JP-002181439
• Act as the regulatory affairs representative on new product development and or RA lifecycle management for assigned product portfolio • Provide oversight and or work on client regulatory projects, develop sound regulatory strategies to support long-term registrations of new or modified products (re: amendments) (e.g. PMA, IDE, 510(k)s, Technical Files, Dossiers, EU MDR, etc.) for domestic and foreign submissions, registrations and reporting: o Maintain electronic systems: EU Technical Files, International dossiers, change assessments o Responsible for ensuring Regulatory policies, SOPs and Procedures are properly developed, approved and maintained; continue to seek and implement cost improvement projects to gain efficiency • Lead in the understanding and awareness of the USA, EU and other international regulatory requirements to ensure compliance. • Drive continuous improvements through observation, measurement and root cause analysis/resolution • Develop and maintain tools to manage team activities workflow • Performs additional duties or assignments and special projects as directed by management. May be asked to support client projects on an ad hoc basis, depending on requirement and resource allocation
regulatory affairs, EU MDR, risk assessment, project management, regulatory, study protocols, clinical study reports, edc, ctms, ich gcp, risk base monitoring, risk management, regulatory submissions, medical device, pma, fda
Top Skills Details:
regulatory affairs,EU MDR,risk assessment
Additional Skills & Qualifications:
• At a minimum, completion of a Bachelor's (e.g. Life/Physical Science, Engineering, Business, etc.) is required. Additional training in regulatory affairs, quality assurance, project management, risk management, etc. is strongly preferred. Advance degree is also strongly preferred. • A minimum of 4+ year of related job experience is required for this position. • Experience within the medical device and biotechnology industry and expert knowledge of FDA (required), EU (required) and Canada (highly preferred) regulatory requirements is a must. • Proven experience contributing to FDA submissions, 510(k) submissions and Letters To File. • Strong computer skills in appropriate software applications and related systems required. • Demonstrated knowledge and experience in the following areas: new product development, regulatory submission, compliance, complaint handling, medical device risk management processes, regulatory policy are preferred. • Project management experience is preferred. • Experience mentoring/coaching and providing training to others is preferred. • Must have strong written and oral communication skills. • Must have a flexible mindset with the ability to work in a fast-changing environment. • Ability to travel to support client and company meetings is a must (up to 25%); for domestic, trans-border and international, as required
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Rehat Singh
Phone: (973) 829-4395