US - Regulatory Affairs Specialist-Sr

A client of Innova Solutions is immediately hiring for a Regulatory Affairs Specialist-Sr

Role : Regulatory Affairs Specialist-Sr

Position type : Full- time Contract

Duration : 12 months

Location : Cordova TN 38018 USA

As a Regulatory Affairs Specialist-Sr, your responsibilities :

• Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.
• Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
• Manage / lead regulatory-driven project, as directed by management.
• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products.
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology.
• Plan, lead and support for internal and Regulatory agency audits
• Lead and direct engagement with regulatory authorities as required
• Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance.
• Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
• Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams.
• Review product labeling to ensure compliance with regulatory requirements Other activities as assigned.

Qualified candidates should APPLY NOW for immediate consideration!  Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines.

Thank you!

Namrata Gautam

PHONE : (+1) 314-523-1818

EMAIL : Namrata.Gautam@innovasolutions.com

PAY RANGE AND BENEFITS :

Pay Range

Benefits :  Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS : Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions :

Website : https : / / www.innovasolutions.com /

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https : / / innovasolutions.workllama.com / atsuser / anonreferafriend  and earn $250-$1,000 per referral.

Innova Solutions  is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.  If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed.  Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.   Innova Solutions (HireGenics / Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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Thank you

Best regards,