Senior Regulatory Affairs Specialist

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

**Position Summary**:
The APAC Senior Regulatory Affairs Specialist supports and improves STERIS’s regulatory position by execution of regulatory and compliance tasks to help achieve business objectives. Successfully execute local and international regulatory affairs and compliance activities for all company product lines. Determine regulatory strategies, plans and procedures pertaining to company product lines. Determine regulatory implications and requirements for new and revised products. Prepare and submit regulatory submissions to government agencies.

**Duties**:

- Successfully execute local and international regulatory affairs and compliance activities for all company product lines
- Support regulatory strategies, plans and procedures pertaining to company product lines
- Prepares regulatory submissions and internal documentation for product changes and new product development
- Acts as company representative, developing and maintaining positive relationships with regulatory authorities
- Provide leadership and on-site guidance as needed for regulatory compliance inspections/audit of Cantel Malaysia facility
- Lead in maintaining and organizing the regulatory affairs files and documentation
- Works with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies.
- Maintains proficiency in government regulations and guidance.
- Develops and maintains procedures to ensure compliance and support business goals.

**Profile required**:
The Regulatory Affairs Senior Specialist has primary responsibility for the obtainment of product and country market registration requirements; in turn supporting their direct Customers and Supervisor.

**Knowledge, Skills and Ability Required for Position**:

- Developed knowledge of international regulations in the area of medical devices, ISO 13485, ASEAN CSDT
- Experience in writing regulatory submissions
- Ability to explain and resolve differences in regulations
- Ability to effectively manage multiple projects and priorities
- General computer knowledge and experience using Microsoft Office software

**IDEAL CANDIATE PROFILE**:

- Strong written and oral skills
- Strong attention to detail
- Ability to multi-task and track regulatory commitments and strong team player

**Education Degree**:

- Bachelor's Degree- Associate's Degree in Biological Science or Science**Required Experience**:

- Minimum an associate degree plus 2 - 5 years' work experience, or Bachelor's Degree with 1 - 3 years' work experience
- Minimum one-year previous government relations and regulatory experience.
- Government agency and / or dealer/consultant experience required.
- Some understanding of chemical / medical device industry, in particular the workings of the regulatory and legislative environment around the world.
- Comprehension of industry developments and changes in the political environment.
- Ability to interact effectively and credibly at senior levels.
- Demonstrated excellence in the following: communication skills, listening skills, interpersonal skills, cross BU team coordination, planning, research, diplomacy, advocacy and sales skills.
- Ability to operate in a business devein model providing quick, salient analysis and concrete action plans with emphasis on understanding and anticipating business needs and interests and devising proactive approaches / responses.

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.