13 days old

Regulatory Affairs Specialist

Kelly Services
Skaneateles Falls, NY 13153
If interested, please send your resume to

**Regulatory Affairs Specialist** (Skaneateles, NY or Remote)

We are a $2.9B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products, and information technology solutions. Our comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.

**Job Description**

Responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s} and communication of general regulatory requirements in support of licensing of products. Serves as a consultam to managers. Manage regulatory activities relating to specific global portfolio of products/projects.

**Essential Duties & Responsibilities**

+ Initiate and develop complex regulatory project plans

+ Identify & prioritize key areas of regulatory risk

+ Provide regulatory device to project teams.

+ Respond to complex questions from regulatory authorities within strict timelines

+ Compile and submit in a timely manner, regulatory documents according to regulatory requirements

+ Maintain and update device listing regulatory authorizations

+ Manage regulatory activities relating to specific portfolio of products/projects

+ Prepare, review. and approve labeling and SOPs

+ Lead or represent Regulatory Affairs in project teams

+ Provide guidance and coaching for areas of responsibility to lower-level team members

+ Monitor applicable regulatory requirements

+ Create and maintain regulatory files in a format consistent with requirements


+ Knowledge of regulations

+ Solid Understanding of EU MDR and ancillary directives

+ Scientific knowledge

+ Project management skills

+ Manage multiple projects, and deadlines

+ Ability to multitask and prioritize

+ Interpersonal and communication skills

+ Strong negotiation skills

+ Technical system skills (e.g., word processing, spreadsheets, databases, online research)

+ Ability to work effectively in multinational/multicultural environment

+ Ability to identify compliance risks and escalate when necessary

**Education / Experience:**

+ Bachelor's degree or country equivalent in a scientific discipline

+ Minimum of 5 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-05-06 Expires: 2022-06-06

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Regulatory Affairs Specialist

Kelly Services
Skaneateles Falls, NY 13153

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