Remote: Regulatory Affairs Specialist

Great Medical Device Company looking for RA Specialist to join ASAP! REMOTE based role with up to 25% travel!!!

Additional Skills & Qualifications:

• At a minimum, completion of a Bachelor's (e.g. Life/Physical Science, Engineering, Business, etc.) is required. Additional training in regulatory affairs, quality assurance, project management, risk management, etc. is strongly preferred. Advance degree is also strongly preferred.

• A minimum of 4+ year of related job experience is required for this position.

• Experience within the medical device and biotechnology industry and expert knowledge of FDA (required), EU (required) and Canada (highly preferred) regulatory requirements is a must.

• Proven experience contributing to FDA submissions, 510(k) submissions and Letters To File.

• Demonstrated knowledge and experience in the following areas: new product development, regulatory submission, compliance, complaint handling, medical device risk management processes, regulatory policy... are preferred.

• Experience mentoring/coaching and providing training to others is preferred.

• Ability to travel to support client and company meetings is a must (up to 25%); for domestic, trans-border and international, as required

Description:

Will be helping as a Regulatory Affairs Specialist, authoring submissions for EU/FDA/ Health Canada. This company encounters a lot of situations dealing with mergers, acquisitions and sell-offs of various products / business units. This role will be involved with determining the regulatory implications / impacts associated with these situations. As most of the products are primarily sold in the US, EU and Canada, knowledge of the regulatory environments is important - FDA, EU and preferably Health Canada.

• Act as the regulatory affairs representative on new product development and or RA lifecycle management for assigned product portfolio

• Provide oversight and or work on client regulatory projects, develop sound regulatory strategies to support long-term registrations of new or modified products (re: amendments) (e.g. PMA, IDE, 510(k)s, Technical Files, Dossiers, EU MDR, etc.) for domestic and foreign submissions, registrations and reporting:

o Maintain electronic systems: EU Technical Files, International dossiers, change assessments

o Responsible for ensuring Regulatory policies, SOPs and Procedures are properly developed, approved and maintained; continue to seek and implement cost improvement projects to gain efficiency

• Lead in the understanding and awareness of the USA, EU and other international regulatory requirements to ensure compliance.

• Drive continuous improvements through observation, measurement and root cause analysis/resolution

• Develop and maintain tools to manage team activities workflow

• Performs additional duties or assignments and special projects as directed by management. May be asked to support client projects on an ad hoc basis, depending on requirement and resource allocation

Skills:

regulatory affairs, EU MDR, risk assessment, project management, regulatory, study protocols, clinical study reports, edc, ctms, ich gcp, risk base monitoring, risk management, regulatory submissions, medical device, pma, fda

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law