Easter Seals Jobs

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We are currently seeking a Senior Regulatory Specialist to join our Foot & Ankle Division to be based in Memphis, Tennessee.

As the Senior Regulatory Affairs Specialis t, you will provide regulatory support in Stryker’s Foot and Ankle (http://www.stryker.com/us/en/portfolios/orthopaedics/foot-and-ankle.html) business unit to obtain and maintain US and global market access. You will engage with cross-functional teams, develop global regulatory strategies, support regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes.

What you will do

• Develop and implement processes involved with maintaining annual licenses, registrations, and listings

• Review and approve advertising and promotion to ensure regulatory compliance

• Submit notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge

• Provide regulatory input and appropriate follow-up for inspections and audits

• Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes

• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

• Negotiate with regulatory authorities throughout the product lifecycle

• Identify the need for new regulatory procedures, SOPs, and participates in development and implementation

• Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

What you need

• Bachelors Degree in Engineering, Science, or related area required

• Minimum 2 years of experience supporting regulatory submissions required

Preferred

• Masters in Regulatory Affairs

• RAC

• NPI

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.