The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Visa sponsorship not available.

Our client is seeking a Principal Regulatory Affairs in Boston.

Skills & Requirements

Relevant Scientific degree
RAPS certification preferred
Strong understanding of regulations, harmonized and recognized standards and guidance of medical devices
Strong understanding and knowledge of ISO 13485, 21 CFR 820, AIMD 90/385/EEC requirements / EU MDR 2017/745
Proven experience in regulatory submissions and registrations
At least 5 years of regulatory experience in medical device industry
At least 7 years of relevant CE, FDA and CMDR regulatory experience
Good level of knowledge and experience working with relevant standards such as ISO 14971, IEC 60601 series, ISO 10993
Experience and knowledge with the ETO sterilization process and the ISO 11737-1/11737-2 requirements.
Experience writing regulatory plan and strategies
Direct experience interacting with regulatory agencies, competent authorities, and third-party affiliates.
Languages: Fluent in English

Responsibilities:

Responsible for the planning of regulatory activities. Develops and implements strategies with the goal of market access in identified geographies
Acts as a core team member on development teams as Regulatory Affairs subject matter expert providing feedback and guidance throughout the product development lifecycle
Plan, coordinate and prepare document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and other global regulatory agencies
Negotiate and interact with regulatory authorities during the development and review process
In collaboration with R&D maintain list of applicable standards
Responsible for regulatory compliance and adherence with regulatory requirements
Perform gap assessments and communicate standard/regulation changes and updates to staff and management as needed
Coordinate with the clinical team on IDE supplements and/or amendments to update clinical investigational and protocol information as needed
Evaluate proposed product changes and prepare ECO Regulatory Plans
Provide regulatory support and guidance to clinical, R&D, operations departments, and project teams and staff as needed
Interpret Company Policy
Participate in internal and external audits as needed
Mentor junior members of the Regulatory team
Review complaints for MDR reporting and submission to FDA.

Benefits/Other Compensation:

Medical, Dental, Life Insurance, 401K.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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