Regulatory Affairs Specialist (F/M/D)

Position Summary

The Regulatory Affairs Specialist is responsible for identifying and obtaining scientific, engineering, and regulatory information for review, preparation, and maintenance of technical documentation for submission to regulatory authorities in the countries / regions where the company wishes to market medical products.

Position holder works with the regulatory authorities, or with the local subsidiaries or distributors taking action on behalf of the company, to ensure compliant market access.

In addition, this person is responsible for review of promotional material and labeling for compliance with regulations, overseeing annual establishment registrations and device listings, and supporting on-going compliance projects.

The RA Specialist reports to the Head of Regulatory Affairs for ClearCorrect Operating, LLC.

Job Responsibilities

Responsible for, but not limited to, the following

• Coordinate acceptance and management of requests for regulatory activities (i.e., Orbit requests).
• Generate and review regulatory submissions to obtain compliant market access for distribution of ClearCorrect brand medical products in target markets / regions;

may also be called on to support the market access activities of other companies within the Orthodontic Business Unit.

Produce subsequent regulatory submissions (renewals, annual reports, change notifications, memos to file, etc.) to maintain market access in the target markets / regions (e.

g., maintains Technical Files and associated documentation for European Union).

• Work with the regulatory authorities (or the local subsidiary or distributor acting on behalf of the company) to achieve market access.
• Provide input to Product Design teams to assure that regulatory requirements and standards are incorporated in the development process;

this may include the preparation and maintenance of the associated Regulatory Strategy.

• Author, review, and / or approve certain Product Design documentation, in consultation with supervisor, complying with design control requirements to facilitate their use in achieving and maintaining access to the markets in which the company participates.
• Assess product and manufacturing process changes to determine if regulatory action is required.
• Support Unique Device Identifier (UDI) requirements in the target markets / regions.
• Review promotional material and labeling to ensure applicable regulatory requirements are met.
• Keep abreast of new or changed regulations, guidance documents, and consensus standards in the target markets / regions and communicate relevant changes to the appropriate internal stakeholders.
• Obtain and maintain establishment registrations and device listings in the target markets / regions.
• Release of products in distribution control system upon receipt of market access and support product launch activities.
• Support Freedom of Information Act requests from the FDA.
• Support logistics / supply chain in providing regulatory information for incoming product shipments.
• Support worldwide registration, including overseeing notarization and legalization of documents and overseeing the request for FDA Certificates to Foreign Government, etc.
• Support specific compliance projects for target markets / regions.
• Other duties as assigned.

Minimum Qualifications

• Technical or scientific degree or equivalent related work experience.
• Minimum 2 years of experience in Regulatory Affairs, other work within the medical device industry, or other work in another regulated industry.
• Bilingual Spanish and English speaker.

Desired Knowledge and Skills

• Good working knowledge of compliance in regulated industry.
• Strong organizational and interpersonal skills.
• Strong written and oral communications skills.
• Detail oriented.
• Proficiency with PC computer and Microsoft Office software
• Technical knowledge of medical devices
• Able to manage multiple projects with shifting priorities
• Able to work independently with limited supervision
• Able to manage complex problems / projects by exercising independent decision making and analytical thinking skills, with limited supervision

Equal Opportunity and Affirmative Action Employer (US applicants only)

Straumann Group is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national origin, age, veteran status, or disability unrelated to job requirements.

Straumann Group will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status.

In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, Straumann Group has developed and maintains an affirmative action program and plan.

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