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29 days old

Principle Regulatory Affairs Specialist

Kelly Services
Andover, MN 55304
Principal Regulatory Specialist (Andover, MN)


Our client, the largest sensor company in the world, is currently hiring a Sr. Level Regulatory Manager to assure Regulatory compliance for Medical Devices. They will work on maintaining the existing 510ks and CE marks, along with managing process for any regulatory updates to existing parts or new parts.


Responsibilities:

Work closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure compliance to 231 CFR 820, ISO 13485, MDD/MDR, MDSAP, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Develop and implement domestic and international strategies for regulatory approval of Class I and II medical devices.

Research and advise company on country specific international product registration and compliance related requirements.

Responsible for submission preparation and development of labeling, marketing or promotional materials, training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.

Prepare submissions for device design changes and /or manufacturing changes.

Develop and maintains positive relationships with regulatory agency staff

Technical and labeling reviews of supporting documents for inclusion in regulatory filings.

Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings.

Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts.

Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact.

Review and approval of marketing materials Lead and/or participate in regulatory audits, as required.


Qualifications:

A minimum of a bachelors degree (technical discipline preferred).

A minimum of 8 years of regulatory affairs or related experience, or 5 years experience with an advanced degree (Masters or PhD).

Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs.

Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations.

Ability to work effectively within a team in a fast-paced changing environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Able to work independently with minimal supervision

Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control.

Demonstrated leadership, strategic thinking, project planning, and project management skills.


**\#TJP2022_SPEC**


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


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-04-20 Expires: 2022-05-21

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Principle Regulatory Affairs Specialist

Kelly Services
Andover, MN 55304

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