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20 days old

Regulatory Affairs Manager

Kelly Services
Rochester, NY 14651
**Regulatory Affairs Specialist**


Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a long-term contract opportunity for a Regulatory Affairs Specialist with our client, a leader in the Medical Device industry, located in Rochester, NY.


Remote option


+ **OBJECTIVES/ PURPOSE OF JOB** The Regulatory Affairs Specialist handles all regulatory development aspects of contact lenses and solutions. Participates on product development teams to provide regulatory guidance for devices assigned, manage relevant regulatory strategy components, interacts with Regulatory Authorities for their assigned products and interacts with other departments to provide regulatory support.

+ **KEY ACTIVITIES/ RESPONSIBILITIES**

+ Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development

+ Develop a product regulatory timeline aligned to the companys product development, with key regulatory milestones, and activities for agency filing

+ **Coordinate with the team on the development of product labels**

+ **Ensure labeling content and product documentation is developed in accordance with regulatory requirements Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions**

+ **Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities**

+ **Act as a regulatory contact for assigned devices**

+ Manage interactions with other departments (e.g., Quality, Compliance) during Regulatory Authority inspections

+ Provide regulatory guidance/input to device change control and internal

+ QUALIFICATIONS/ TRAINING Technical Competencies

+ Knowledge of device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations

+ Knowledge of US laws, regulations, and guidance that affect assigned devices

+ Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses

+ Ability to interpret FDA policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices

+ Ability to influence and partner with cross-functional teams

+ Ability to take innovative ideas from proof of concept the to promote a successful product regulatory strategy and increase probability of regulatory approval

+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data

+ Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks Professional Competencies:

+ Demonstrated ability in analytical reasoning and critical thinking skills

+ Strong capability to contribute and lead a team environment

+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs

+ Demonstrated ability to contribute to a continuous learning and process improvement environment

+ Capacity to react quickly and decisively in unexpected situations

+ Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies

+ Focused ability to influence operational excellence and performance metrics

+ Risk-averse of where needed with the ability to identify potential solutions to complex problems

+ **EXPERIENCE**

+ 5-7 years relevant medical device industry and regulatory experience

+ Ophthalmic device regulatory experience highly preferred

+ Bachelors degree in science or health-related field Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)


+ Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.


**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** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-05 Expires: 2022-10-15

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Regulatory Affairs Manager

Kelly Services
Rochester, NY 14651

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