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30 days old

Regulatory Affairs Specialist IV

Kelly Services
Andover, MA 01812
Kelly is seeking a **Regulatory Affairs Specialist IV** for one of our medical device clients in **Andover, Massachusetts.**


+ **Need** MDR experience with Class I, II and III devices (ortho or spine is preferred).

+ pay: $60-80/hr

+ 1 year contract


The Regulatory Affairs Specialist will develop and implement regulatory strategies, focused on Orthopedic products and on achieving compliance with the upcoming European Medical Device Regulation. The Regulatory Affairs Specialist will be responsible for providing regulatory input and strategic direction for upgrading existing technical files and ensuring that new product are also compliant to the new requirements. Current business-critical projects include: product rationalization (part number reduction), revision and upgrading of existing Design History Files and other regulatory documents, transfer of product registrations between companies and strategic planning to ensure optimal business continuity.


ESSENTIAL DUTIES AND RESPONSIBILITIES

Using a broad base of knowledge and understanding of regulatory requirements, this person helps lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for our International business.

Evaluates regulatory issues, develops regulatory strategies and revises technical documentation for upcoming regulatory submissions for orthopedic products.

Develops US and International regulatory strategies and verification and validation activities for assigned product submissions

Actively assists with our upcoming audits and certification reviews with Notified Body (BSI).

Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements)

Reviews promotional and advertising material for adherence to approved product claims.

Works in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with European and International regulations.

Coordinates roll-outs of product changes with corporate and international regulatory teams.

Ensures timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators.


DESIRED MINIMUM QUALIFICATIONS


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable.


EDUCATION


Bachelors degree in science or other technically related field, or equivalent work experience.


TYPE AND NUMBER OF YEARS OF EXPERIENCE


Minimum of 5 years regulatory experience with increasing responsibility in a medical device or pharmaceutical company, or familiarity with orthopedic product development in a technical role.

Experience in working effectively with cross-functional teams; especially with manufacturing sites.

Experience with orthopedic or implantable products is preferred, but not required.

Awareness of business strategies and tactics, including an understanding of regulatory impact.

Must have proven ability to prepare and submit documents to regulatory agencies.

Ability to explain regulatory requirements and pitfalls to project teams and colleagues.

Can communicate existing facts in an organized and clear manner to cross-functional teams.

Must be detail oriented, well-organized and able to work both independently and in teams.

Must possess and demonstrate an understanding of FDA, MDR requirements and quality system requirements.

Demonstrated sense of humor, and the capacity to enjoy working in a great team.


SKILLS

Must have strong writing, project management and communication skills.

Demonstrated skills in contributing to multiple projects simultaneously.

Awareness of business strategies and tactics, including regulatory impact.

Can communicate facts in an organized and clear manner to cross-functional teams.

Established skill in objective thinking.

Provides regulatory input to cross-functional teams.

Brings proposals for solutions to identified issues.

Develops plans to meet pre-defined Regulatory goals.

Responsible for tasks and simple submission components, based on templates

Ability to explain regulatory requirements and pitfalls to project teams and colleagues.

Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.

Willingness to take ownership and accept responsibility for actions and decisions.

Must be detail oriented, well organized and able to work both independently and in teams.

Ability to communicate effectively in both informal and formal settings.


CERTIFICATION

Regulatory Affairs Certification (RAC) is a plus, and can be obtained on the job.


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-21 Expires: 2021-06-21

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Regulatory Affairs Specialist IV

Kelly Services
Andover, MA 01812

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