What are the responsibilities and job description for the Regulatory Affairs Specialist position at Actalent?
Equivalent Experience
Description:
This role will be involved with determining the regulatory implications / impacts associated with Zimmer's Class II product lines. 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.
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
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.
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.
Description:
This role will be involved with determining the regulatory implications / impacts associated with Zimmer's Class II product lines. 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. 510(k)s, Technical Files, Dossiers, EU MDR, etc.) for domestic and foreign submissions, registrations and reporting:
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
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 years 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.
- Strong computer skills in appropriate software applications and related systems required.
- 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.
- Project management experience is preferred.
- Must have strong written and oral communication skills.
- Must have a flexible mindset with the ability to work in a fast-changing environment.
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.